Venlafaxine ER Long-Term Extension Study for Major Depressive Disorder (MDD)
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 12% of the time (422 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2014-01-31, after 2012-01-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2014-01-31. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: long termextensiondouble blindsubjectsmajor
Phrases that lowered it: weeksopenweeklabelvisit -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Minimum age: 20 (lowers risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Sponsor's past termination rate: 9.4% (raises risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 50 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 78.8% (lowers risk) · Drug's FDA history
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Sponsor's past trials: 286 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 10.2% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports before start: 29028 (lowers risk) · Drug's FDA history
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Maximum age: not given (lowers risk) · Who can join
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 3 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 286 (typical: 32)
- Sponsor's past termination rate
- 9.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 50 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 29028 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5076 (typical: 412.5)
- Drug's FAERS reports marked serious
- 78.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- venlafaxine
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD NCT01371708 · started 2012 · scored riskier than 97% of active trials completed
- A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD NCT01371721 · started 2012 · scored riskier than 95% of active trials completed
- Open-label Safety Extension Study of 2.5, 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults NCT00694304 · started 2008 · scored riskier than 13% of active trials completed
- Venlafaxine ER Phase 3 Study for Major Depressive Disorder (MDD) NCT01441440 · started 2011 · scored riskier than 13% of active trials completed
- Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder NCT00707980 · started 2008 · scored riskier than 17% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.