This page shows what was measured, who it was measured in, and what that does not settle.
What Vortioxetine does in the body
Major depressive disorder
From the FDA-approved label: The mechanism of the antidepressant effect of vortioxetine is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through inhibition of the reuptake of serotonin (5-HT). It also has several other activities including 5-HT3 receptor antagonism and 5-HT1A receptor agonism. The contribution of these activities to vortioxetine's antidepressant effect has not been established.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · TKS641KOAY · read 2026-08-29
Its recorded molecular formula is C18H22N2S, weighing 379.36 g/mol.
US prescribing information · 1a5b68e2-14d0-419d-9ec6-1ca97145e838 · read 2026-08-30
Where each sentence above came from
The recorded explanation is written in label language rather than for a beginner. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 82 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Mood
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
…Waiting for a reviewer8 registered symptom measure.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Pain
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
…Waiting for a reviewer1 registered symptom measure.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Mood
madrs total after 8 weeks of treatment; 24 item hamilton depression scale total at week 8; hamilton anxiety scale total at week 8; hamilton anxiety scale total; montgomery sberg depression rating scale total; montgomery and asberg depression rating scale; montgomery asberg depression rating scale; montgomery sberg depression rating scale
Pain
short form mcgill pain questionnaire
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
… Waiting for a reviewer
8 registered symptom measure.
— Not recorded
Harms were not a registered measure for this goal.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Time From Randomization to Relapse of Major Depressive Disorder During the First 28 Weeks of the 32-Week Double-Blind Treatment Period
✗ The study did not show it
Who was studied
NCT02371980
How many people
1106
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Number of Participants With Treatment-Emergent Adverse Events at a Frequency Threshold of ≥5%
✗ The study did not show it
Who was studied
NCT01152996
How many people
1075
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Physical Examination Findings
✗ The study did not show it
Who was studied
NCT00707980
How many people
836
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment
✗ The study did not show it
Who was studied
NCT02709746
How many people
784
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8
✗ The study did not show it
Who was studied
NCT00730691
How many people
781
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Change From Baseline in MADRS Total Score After 8 Weeks of Treatment
✗ The study did not show it
Who was studied
NCT00635219
How many people
766
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.2 registered measures of this kind. No reviewed result.
■What a body can do day to dayEvidence recorded. Walking, dressing, breathing, recovering.1 registered measure of this kind.
■Measured performanceEvidence recorded. How much was lifted, how far was run, how fast.1 registered measure of this kind.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.9 registered measures of this kind.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
madrs total after 8 weeks of treatment
24 item hamilton depression scale total at week 8
hamilton anxiety scale total at week 8
hamilton anxiety scale total
montgomery sberg depression rating scale total
montgomery and asberg depression rating scale
montgomery asberg depression rating scale
short form mcgill pain questionnaire
montgomery sberg depression rating scale
Measured
Things only a test, a scale or a device shows.
No registered study measured anything of this kind.
Meaningful
Things that change how a life goes, not only a number.
time to relapse
sheehan disability scale
progression free survival
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (28)
adverse events
who withdrew due to intolerance to treatment
physical examination findings
ham d 24 total after 8 weeks of treatment
serious treatment emergent adverse events
reporting one or more treatment emergent adverse events
vital signs
electrocardiograms
battery of eeg measurements
digit symbol substitution test
digit symbol substitution test number of correct symbols
panic disorder severity scale
binge eating episodes
treatment emergent adverse events
incidence of treatment emergent adverse events
withdrawing from treatment due to adverse events
medication possession during first 180 days of treatment
persistence during first 180 days of treatment
who adhered to treatment measured by mpr
experiencing recurrence during the acute treatment phase
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 66 hours hours
Read from the label, which states: “The mean terminal half-life is approximately 66 hours, and steady-state plasma concentrations are typically achieved within two weeks of dosing.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults. TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults ( 1, 14 ).
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of TRINTELLIX have not been established in pediatric patients.”
US prescribing information · 1a5b68e2-14d0-419d-9ec6-1ca97145e838 · read 2026-08-30
On older people, the label states: “Of the 2,616 subjects in clinical studies of TRINTELLIX, 11% (286) were 65 and over, which included subjects from a placebo-controlled study specifically in elderly patients [see Clinical Studies (14) ] .”
US prescribing information · 1a5b68e2-14d0-419d-9ec6-1ca97145e838 · read 2026-08-30
On people who are pregnant, the label states: “Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy.”
US prescribing information · 1a5b68e2-14d0-419d-9ec6-1ca97145e838 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of vortioxetine in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · 1a5b68e2-14d0-419d-9ec6-1ca97145e838 · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S6.
No source is stored against this line.
What is in the pack
Sold as tablet, tablet:film coated, tablet, film coated, given by the oral route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Vortioxetine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2514 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
nausea — 783 reaction mentions
suicidal ideation — 330 reaction mentions
vomiting — 315 reaction mentions
pruritus — 231 reaction mentions
anxiety — 202 reaction mentions
depression — 157 reaction mentions
suicide attempt — 150 reaction mentions
feeling abnormal — 145 reaction mentions
agitation — 101 reaction mentions
serotonin syndrome — 100 reaction mentions
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
23 products list this as an active ingredient in the United States drug directory. 23 of them contain it and nothing else.
FDA National Drug Code directory · 87832-0310 · read 2026-08-29
They are sold as powder and tablet, film coated, taken oral.
FDA National Drug Code directory · 87832-0310 · read 2026-08-29
4 published labels name it as an active ingredient. 4 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 1a5b68e2-14d0-419d-9ec6-1ca97145e838 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 1a5b68e2-14d0-419d-9ec6-1ca97145e838 · read 2026-08-29
Trintellix is oral at 3 DOSAGE FORMS AND STRENGTHS TRINTELLIX is available as: 5 mg: pink, almond shaped biconvex film coated tablet, debossed with "5" on one side and "TL" on the other side 10 mg: yellow, almond shaped biconvex film coated…, recorded as fda label in effect 2025-03-05 in the United States.
US prescribing information · 1a5b68e2-14d0-419d-9ec6-1ca97145e838 · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Vortioxetine studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Vortioxetine are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
How many documents were read
4 documents were read for this substance.
RNAWiki source record
4 of them state the same halfLife, and they agree.
RNAWiki source record
4 of them state the same bioavailability, and they agree.
RNAWiki source record
4 of them state the same proteinBinding, and they agree.
RNAWiki source record
4 of them state the same volumeOfDistribution, and they agree.
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Where else this substance is registered
FDA substance identifier (UNII)
TKS641KOAY
RxNorm concept
1439808
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How this medicine reached us
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8 approved applications cover products containing this substance. The earliest was NDA204447, approved 20130930 to TAKEDA PHARMS USA.
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5 questions this page could not answer
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Recorded evidence blocks (14)
Q2
What did Vortioxetine's largest trial (370212 people) and its longest (8.3 years) measure?
370212 people in Vortioxetine's largest registered study, 8.3 years in its longest registered window, measuring Maximum Concentration of 5-HT in Plasma. ClinicalTrials.gov · 2026-09-01
46 phase3, 27 phase4, 19 phase2, 9 phase1, 5 na or unstated, 2 early phase1, 1 na; NCT02357797; 2024-06-01. Last human test completed 2026, NCT07000734.
Interpretation These counts include studies where Vortioxetine was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase3
46
phase4
27
phase2
19
phase1
9
na or unstated
5
early phase1
2
2 more recorded rows
na
1
Last recorded human testNCT07000734
2026-04-30
recorded 2026-09-01 · last checked 2026-09-04
Q3
Vortioxetine was tested only in human — what did it show?
14 recorded entries; human; tablet, infusion; also "Vortioxetine 10 mg", "Vortioxetine 20 mg", "Vortioxetine 10-20 mg"
Show the evidence
human
NCT02072278
Vortioxetine 10 mg
NCT02072278
Vortioxetine 20 mg
NCT02272517
Vortioxetine 10-20 mg
NCT02327013
tablet; vortioxetine 10 mg tablet
NCT02327013
tablet; vortioxetine 20 mg tablet
NCT02386488
Vortioxetine 10 mg single dose
8 more recorded rows
humanNCT02386488
Vortioxetine 20 mg single dose
humanNCT02386488
Vortioxetine 10 mg multiple dose
humanNCT02386488
Vortioxetine 20 mg multiple dose
humanNCT02709655
Vortioxetine 10 mg/day
humanNCT02709655
Vortioxetine 20 mg/day
humanNCT03766867
infusion; Vortioxetine infusion 25 mg
humanNCT03766867
Vortioxetine tablets 10 mg/day
humanNCT06025474
Vortioxetine 20Mg Tab
recorded 2026-09-01 · last checked 2026-09-04
Q6
Vortioxetine's half-life is 66 hours — which schedules were studied?
66 hours, the half-life Vortioxetine's label states. openfda-label · 239215eb-be32-4286-9677-1e5556c6cccf · 2026-08-30
bioavailability 75% %.
Show the evidence
half life
66 hours hours; The mean terminal half-life is approximately 66 hours, and steady-state plasma concentrations are typically achieved within two weeks of dosing.
tmax
Absorption The maximal plasma vortioxetine concentration (C max ) after dosing is reached within 7 to 11 hours postdose (T max ).
bioavailability
75% %; Absolute bioavailability is 75%.
metabolism
Elimination Metabolism Vortioxetine is extensively metabolized primarily through oxidation via cytochrome P450 isozymes CYP2D6, CYP3A4/5, CYP2C19, CYP2C9, CYP2A6, CYP2C8, and CYP2B6 and subsequent glucuronic acid conjugation.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of 24 item hamilton depression scale total at week 8, adverse events and adverse events within maintenance phase of treatment did Vortioxetine's trials measure?
24 item hamilton depression scale total at week 8, adverse events and adverse events within maintenance phase of treatment lead 40 outcome terms across Vortioxetine's trials. ClinicalTrials.gov · 2026-09-01
who withdrew due to intolerance to treatment, physical examination findings, hamilton anxiety scale total at week 8, hamilton anxiety scale total, time to relapse and ham d 24 total after 8 weeks of treatment follow.
Show the evidence
madrs total after 8 weeks of treatment
1
24 item hamilton depression scale total at week 8
1
adverse events
1
who withdrew due to intolerance to treatment
1
physical examination findings
1
hamilton anxiety scale total at week 8
1
14 more recorded rows
hamilton anxiety scale total
1
time to relapse
1
ham d 24 total after 8 weeks of treatment
1
serious treatment emergent adverse events
1
montgomery sberg depression rating scale total
1
reporting one or more treatment emergent adverse events
1
vital signs
1
electrocardiograms
1
battery of eeg measurements
1
digit symbol substitution test
1
digit symbol substitution test number of correct symbols
1
panic disorder severity scale
1
binge eating episodes
1
montgomery and asberg depression rating scale
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Vortioxetine's 8 ongoing trials reports first?
Change in CDRS-R (Children's Depression Rating Scale) scores from baseline; Prediction of the therapeutic response (MADRS score) 28 days after the introduction of the antidepressant strategy (V3) based on the early changes (differences between V1 and V2)…; latest 2030-12-31
Show the evidence
Trial
NCT05814640
"Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)"; n 520; "Change in CDRS-R (Children's Depression Rating Scale) scores from baseline"; 2027-07-01
NCT05866575
"Prediction of the Therapeutic Response in Depression Based on Neuro-computational Modeling Assessment of Motivation"; n 136; "Prediction of the therapeutic response (MADRS score) 28 days after the introduction of the antidepressant strategy (V3) based on the early changes (differences between V1 and V2) of the computational phenotype of depressed patients."; 2026-11-12
NCT06604520
"Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia"; n 50; "Change in global cerebral glucose metabolism on [18F] fluorodeoxyglucose Positron Emission Tomography (FDG PET)"; 2029-09-01
NCT06805266
"Vortioxetine for Depressive Symptoms and Freezing of Gait in Parkinson Disease"; n 40; "Change in the score of the Freezing Of Gait (FOG) Questionnaire referred to the "on state""; 2027-02
NCT07204314
"A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder"; n 180; "Change from Baseline in the Children Depression Rating Scale Revised version (CDRS-R) Total Score"; 2029-09-30
NCT07266545
"RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)"; n 120; "Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score"; 2030-12-31
2 further recorded trials
NCT07284628
"Vortioxetine for Newly Diagnosed Glioblastoma"; n 78; "Progression-free survival (PFS)"; 2029-06
NCT07741331
"Compare the Efficacy and Safety of KH607 Tablets Versus Vortioxetine Hydrobromide Tablets in Adult Patients With Major Depressive Disorder"; n 326; "short-term study: Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score"; 2028-12
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Vortioxetine could settle lifespan?
NCT07284628 measures Progression-free survival (PFS), reading out 2029-06.
1 open trial; n 78; "Vortioxetine for Newly Diagnosed Glioblastoma"
Show the evidence
TrialNCT07284628
"Vortioxetine for Newly Diagnosed Glioblastoma"; n 78; "Progression-free survival (PFS)"; 2029-06
Q10
Which 22 trials of Vortioxetine posted no result?
Posted no result
22 of 22 completed trials
Registrations
NCT00788034, NCT01395147, NCT02386488, NCT02279966, NCT02272517 and NCT02279953, and 16 more
Completion dates
oldest 2010-07; newest 2023-08-15
Show the evidence
Trial
NCT00788034
2010-07
NCT01395147
2013-05
NCT02386488
2015-05
NCT02279966
2016-02
NCT02272517
2016-03
NCT02279953
2016-04
14 further recorded trials
NCT02395510
2016-06
NCT02919501
2017-04-27
NCT02332954
2017-07-06
NCT03978286
2018-06-30
NCT03766867
2019-08-28
NCT03835715
2020-02-21
NCT03108625
2020-04-16
NCT03555136
2021-01-31
NCT04220996
2021-03-09
NCT04448431
2022-02-04
NCT04288895
2022-03-12
NCT04294654
2022-07-20
NCT05417087
2022-09-02
NCT03779789
2023-02-28
Q11
At the median, Vortioxetine's trials enrolled 149.5 people — anything larger?
Median enrolment
149.5
Largest enrolment
370212
Registered trials counted
104
Q12
What do 2514 spontaneous reports say about Vortioxetine — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Vortioxetine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2514 reaction mentions were counted: nausea 783; suicidal ideation 330; vomiting 315; pruritus 231. open-targets-adr · CHEMBL2104993 · 2026-06-24
Show the evidence
nausea
783
suicidal ideation
330
vomiting
315
pruritus
231
anxiety
202
depression
157
4 more recorded rows
suicide attempt
150
feeling abnormal
145
agitation
101
serotonin syndrome
100
recorded 2026-06-24 · last checked 2026-09-04
Q13
Vortioxetine and CYP2B6, CYP2C19 and CYP2C9: shared by which compounds?
CYP2B6, CYP2C19 and CYP2C9 appear in Vortioxetine's recorded interaction sentences, 27 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2
pharmacokinetics
In addition, vortioxetine did not induce CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP3A4/5 in an in vitro study in cultured human hepatocytes.
pharmacokinetics
Impact of Vortioxetine on PK of Other Drugs Figure 3 In Vitro Vortioxetine and its metabolite(s) are unlikely to inhibit the following CYP enzymes and transporter based on in vitro data: CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5, P-gp, BCRP, BSEP, MATE1, MATE2-K, OAT1, OAT3, OATP1B1, OATP1B3, OCT1, and OCT2.
CYP2A6
pharmacokinetics
Elimination Metabolism Vortioxetine is extensively metabolized primarily through oxidation via cytochrome P450 isozymes CYP2D6, CYP3A4/5, CYP2C19, CYP2C9, CYP2A6, CYP2C8, and CYP2B6 and subsequent glucuronic acid conjugation.
pharmacokinetics
In addition, vortioxetine did not induce CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP3A4/5 in an in vitro study in cultured human hepatocytes.
pharmacokinetics
Impact of Vortioxetine on PK of Other Drugs Figure 3 In Vitro Vortioxetine and its metabolite(s) are unlikely to inhibit the following CYP enzymes and transporter based on in vitro data: CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5, P-gp, BCRP, BSEP, MATE1, MATE2-K, OAT1, OAT3, OATP1B1, OATP1B3, OCT1, and OCT2.
CYP2B6
pharmacokinetics
Elimination Metabolism Vortioxetine is extensively metabolized primarily through oxidation via cytochrome P450 isozymes CYP2D6, CYP3A4/5, CYP2C19, CYP2C9, CYP2A6, CYP2C8, and CYP2B6 and subsequent glucuronic acid conjugation.
pharmacokinetics
Furthermore, in a series of clinical drug interaction studies, coadministration of TRINTELLIX with substrates for CYP2B6 (e.g., bupropion), CYP2C9 (e.g., warfarin), and CYP2C19 (e.g., diazepam), had no clinical meaningful effect on the pharmacokinetics of these substrates.
pharmacokinetics
In addition, vortioxetine did not induce CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP3A4/5 in an in vitro study in cultured human hepatocytes.
pharmacokinetics
Impact of Vortioxetine on PK of Other Drugs Figure 3 In Vitro Vortioxetine and its metabolite(s) are unlikely to inhibit the following CYP enzymes and transporter based on in vitro data: CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5, P-gp, BCRP, BSEP, MATE1, MATE2-K, OAT1, OAT3, OATP1B1, OATP1B3, OCT1, and OCT2.
CYP2C19
pharmacokinetics
Elimination Metabolism Vortioxetine is extensively metabolized primarily through oxidation via cytochrome P450 isozymes CYP2D6, CYP3A4/5, CYP2C19, CYP2C9, CYP2A6, CYP2C8, and CYP2B6 and subsequent glucuronic acid conjugation.
pharmacokinetics
Furthermore, in a series of clinical drug interaction studies, coadministration of TRINTELLIX with substrates for CYP2B6 (e.g., bupropion), CYP2C9 (e.g., warfarin), and CYP2C19 (e.g., diazepam), had no clinical meaningful effect on the pharmacokinetics of these substrates.
pharmacokinetics
In addition, vortioxetine did not induce CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP3A4/5 in an in vitro study in cultured human hepatocytes.
pharmacokinetics
Impact of Vortioxetine on PK of Other Drugs Figure 3 In Vitro Vortioxetine and its metabolite(s) are unlikely to inhibit the following CYP enzymes and transporter based on in vitro data: CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5, P-gp, BCRP, BSEP, MATE1, MATE2-K, OAT1, OAT3, OATP1B1, OATP1B3, OCT1, and OCT2.
CYP2C8
pharmacokinetics
Elimination Metabolism Vortioxetine is extensively metabolized primarily through oxidation via cytochrome P450 isozymes CYP2D6, CYP3A4/5, CYP2C19, CYP2C9, CYP2A6, CYP2C8, and CYP2B6 and subsequent glucuronic acid conjugation.
pharmacokinetics
In addition, vortioxetine did not induce CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP3A4/5 in an in vitro study in cultured human hepatocytes.
pharmacokinetics
Impact of Vortioxetine on PK of Other Drugs Figure 3 In Vitro Vortioxetine and its metabolite(s) are unlikely to inhibit the following CYP enzymes and transporter based on in vitro data: CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5, P-gp, BCRP, BSEP, MATE1, MATE2-K, OAT1, OAT3, OATP1B1, OATP1B3, OCT1, and OCT2.
CYP2C9
pharmacokinetics
Elimination Metabolism Vortioxetine is extensively metabolized primarily through oxidation via cytochrome P450 isozymes CYP2D6, CYP3A4/5, CYP2C19, CYP2C9, CYP2A6, CYP2C8, and CYP2B6 and subsequent glucuronic acid conjugation.
pharmacokinetics
Furthermore, in a series of clinical drug interaction studies, coadministration of TRINTELLIX with substrates for CYP2B6 (e.g., bupropion), CYP2C9 (e.g., warfarin), and CYP2C19 (e.g., diazepam), had no clinical meaningful effect on the pharmacokinetics of these substrates.
pharmacokinetics
In addition, vortioxetine did not induce CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP3A4/5 in an in vitro study in cultured human hepatocytes.
pharmacokinetics
Impact of Vortioxetine on PK of Other Drugs Figure 3 In Vitro Vortioxetine and its metabolite(s) are unlikely to inhibit the following CYP enzymes and transporter based on in vitro data: CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5, P-gp, BCRP, BSEP, MATE1, MATE2-K, OAT1, OAT3, OATP1B1, OATP1B3, OCT1, and OCT2.
recorded 2026-08-30 · last checked 2026-09-04
Q14
Was Vortioxetine studied with fasting and exercise?
fasting and exercise are named in Vortioxetine's label sentences: "This study aimed to evaluate the bioequivalence and in vitro dissolution performance of a generic 20 mg vortioxetine formulation compared to the reference product under fasting conditions in healthy Mexican volunteers. <b>Methods:</b> This was a randomized, open-label, two-period, crossover study." openfda-label+europepmc · 2026-08-30
2 recorded statements; fasting, exercise
Show the evidence
fasting
This study aimed to evaluate the bioequivalence and in vitro dissolution performance of a generic 20 mg vortioxetine formulation compared to the reference product under fasting conditions in healthy Mexican volunteers. <b>Methods:</b> This was a randomized, open-label, two-period, crossover study.
exercise
In terms of efficacy, all treatments studied (acupuncture, mirtazapine, herbal medicine, venlafaxine, physical exercise, cognitive-behavioral therapy (CBT), bupropion, fluoxetine, and vortioxetine) except for probiotics were significantly more effective than placebo.
recorded 2026-08-30 · last checked 2026-09-04
Q15
What is recorded about Vortioxetine and autophagy?
"Meanwhile, our findings reveal autophagy inhibitors as an effective sensitizer for vortioxetine, offering new strategies for treating GBM." — where Vortioxetine and autophagy appear together. Europe PMC · pathway abstract search · 2025-01-01
autophagy; PMID 39968089, 32750222
Show the evidence
autophagy
PMID 39968089
"Meanwhile, our findings reveal autophagy inhibitors as an effective sensitizer for vortioxetine, offering new strategies for treating GBM."
PMID 32750222
"Further investigations indicated that vortioxetine regulated apoptosis and autophagy via activation of the phosphoinositide 3-kinase/AKT pathway."
PMID 32750222
"Taken together, our data suggest that vortioxetine has cytotoxic effects against GC AGS cells as a result of inhibiting proliferation, invasion and migration, as well as by inducing apoptosis and autophagy through the phosphoinositide 3-kinase/AKT pathway."
recorded 2025-01-01 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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