Safety and Efficacy of Brexpiprazole in the Treatment of Schizophrenia
Model scores of the 29,894 trials active now.
Model score 10% 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 12% of the time (422 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-09-06, after 2019-11-27 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2021-09-06. 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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Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 4.3% (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 60.3% (lowers risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 5.2% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: triple (raises risk) · Design
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Maximum age: 65 (raises risk) · Who can join
-
Disease area, psychiatry: Yes (raises risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: diabetestypescoreivhba1c
Phrases that lowered it: subjectsthe trialsubjectscreeningevaluate the -
Disease area, neurology: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 6 (raises risk) · Sponsor's track record
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Sponsor's past trials: 23 (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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: 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
- 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
- 23 (typical: 32)
- Sponsor's past termination rate
- 4.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 6 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 85314 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 8647 (typical: 412.5)
- Drug's FAERS reports marked serious
- 60.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- aripiprazole, brexpiprazole
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
- Randomized, Double-blinded, Placebo-controlled, Evaluating the Treatment With LB-102 in Patients With Acute Schizophrenia NCT06179108 · started 2023 · scored riskier than 20% of active trials completed
- Aripiprazole IM Depot in the Acute Treatment of Adults With Schizophrenia NCT03172871 · started 2017 · scored riskier than 16% of active trials completed
- Lurasidone Low-Dose - High-Dose Study Study NCT01821378 · started 2013 · scored riskier than 24% of active trials completed
- The Safety and Efficacy of Brexpiprazole as Adjunctive Therapy in the Treatment of Major Depressive Disorder NCT03487198 · started 2018 · scored riskier than 40% of active trials terminated
- Pediatric Schizophrenia Efficacy and Safety Study NCT01911429 · started 2013 · scored riskier than 11% 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.