Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder

Model scores of the 29,894 trials active now.

Model score 20% 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 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 2014-09-30. 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.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: ivremissionpainmultiple sclerosisalzheimer
  Phrases that lowered it: drugevaluate theto evaluatediabetesand safety
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 11.3% (raises risk) · Sponsor's track record
• Drug's FAERS reports with a death: 5.8% (lowers risk) · Drug's FDA history
• Phase: 3 (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Disease area, psychiatry: Yes (raises risk) · Disease area
• Drug's FAERS reports marked serious: 25.7% (lowers risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 75 (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Blinding: quadruple (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports before start: 3247 (raises risk) · Drug's FDA history
• Maximum age: 75 (raises risk) · Who can join
• Responsible party: sponsor (lowers risk) · Design
• Number of arms: 3 (lowers 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.

• Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder NCT01467713 · started 2011 · scored riskier than 52% of active trials terminated
• Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder NCT01467700 · started 2011 · scored riskier than 40% of active trials terminated
• A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression NCT03543410 · started 2018 · scored riskier than 58% of active trials completed
• Lurasidone Pediatric Bipolar Study NCT02046369 · started 2014 · scored riskier than 20% of active trials completed
• NRX101 Glx Biomarker Validation Study NCT03402152 · started 2018 · scored riskier than 70% 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.