Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (1,304 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 2013-01-31, after 2011-04-30 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 2013-01-31. 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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Phase: 2 (raises risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 9.2% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: bmspatientspurpose ofthe purposepatient
Phrases that lowered it: the efficacyand safetyefficacy andsafety ofevaluate the -
Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports marked serious: 61.3% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 6.2% (lowers risk) · Drug's FDA history
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Blinding: double (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 100 (lowers risk) · Sponsor's track record
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Number of arms: 5 (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports before start: 24067 (raises risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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Collaborators: 0 (raises risk) · Design
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Maximum age: 65 (raises 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
- 2
- Number of arms
- 5 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (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
- 284 (typical: 32)
- Sponsor's past termination rate
- 9.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 100 (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
- 24067 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5299 (typical: 412.5)
- Drug's FAERS reports marked serious
- 61.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- duloxetine
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
- Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression NCT01369095 · started 2011 · scored riskier than 56% of active trials completed
- BTRX-246040 Administered Once Daily to Patients With Major Depressive Disorder NCT03193398 · started 2017 · scored riskier than 40% of active trials completed
- A Trial of GH001 in Patients With Treatment-resistant Depression NCT05800860 · started 2023 · scored riskier than 14% of active trials completed
- Long-term Safety and Tolerability of BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression NCT01361555 · started 2011 · scored riskier than 79% of active trials terminated
- Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression (TRD) NCT05454410 · started 2023 · scored riskier than 53% 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.