A Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia

Model scores of the 29,894 trials active now.

Model score 13% 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 7% of the time (289 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.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2014-03-31. 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 9.5% (raises risk) · Sponsor's track record
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: subjects withacuteplacebo controlledblind placeboheart
  Phrases that lowered it: visitsinglekgmalethe screening
• Phase: 1 (lowers risk) · Design
• Design: single group (raises risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 27 (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Disease area, psychiatry: Yes (raises risk) · Disease area
• Blinding: single (raises risk) · Design
• Sponsor's past trials: 95 (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Disease area, neurology: No (lowers risk) · Disease area
• Number of arms: 2 (raises risk) · Design

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.

• Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia NCT01994473 · started 2013 · scored riskier than 27% of active trials completed
• A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With Schizophrenia NCT02969382 · started 2016 · scored riskier than 45% of active trials completed
• A Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of ASP6981 in Subjects With Schizophrenia NCT03356639 · started 2018 · scored riskier than 8% of active trials completed
• Lurasidone Low-Dose - High-Dose Study Study NCT01821378 · started 2013 · scored riskier than 24% of active trials completed
• A Clinical Study to Investigate the Effect of an Investigational Drug as an Added Medication to an Antipsychotic, in Adults With Schizophrenia, as Measured Positron Emission Tomography (PET) Imaging NCT04038957 · started 2019 · scored riskier than 20% 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.