Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD)
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (269 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
Terminated on 2008-12-11, after 2008-01-25 start.
Reason given by the sponsor: “enrollment”
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 2008-12-11. 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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Sponsor's past termination rate: 3.4% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 546 (raises risk) · Sponsor's track record
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Minimum age: 20 (lowers risk) · Who can join
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Phase: 2 (raises risk) · Design
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Sponsor's past trials: 640 (raises risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports with a death: 10.8% (lowers risk) · Drug's FDA history
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Maximum age: 65 (raises risk) · Who can join
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: single (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- single (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 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
- 640 (typical: 32)
- Sponsor's past termination rate
- 3.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 546 (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
- 4996 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1314 (typical: 412.5)
- Drug's FAERS reports marked serious
- 76.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- paroxetine
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
- Controlled-release Paroxetine in Major Depressive Disorder (Double-blind, Placebo-controlled Study) NCT00866294 · started 2009 · scored riskier than 11% of active trials completed
- Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD) NCT01987960 · started 2013 · scored riskier than 41% of active trials terminated
- Phase II Study of BNC210 in PTSD NCT02933606 · started 2016 · scored riskier than 70% of active trials completed
- Fixed Dose Study of PD 0332334 and Paroxetine for the Treatment of Generalized Anxiety Disorder NCT00836069 · started 2008 · scored riskier than 22% of active trials terminated
- A Study to Test Whether Taking BI 1358894 for 8 Weeks Helps Adults With Post-traumatic Stress Disorder NCT05103657 · started 2021 · scored riskier than 55% 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.