Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder

Model scores of the 29,894 trials active now.

Model score 17% for any early termination, 3% 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 2015-03-31. 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.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: participant hastherapydiagnosiscancerremission
  Phrases that lowered it: and safetyefficacy andsafety ofthe efficacymale
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 12% (raises risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 22.9% (lowers risk) · Drug's FDA history
• Phase: 3 (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Drug's FAERS reports with a death: 5.0% (lowers risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers risk) · Design
• Disease area, psychiatry: Yes (raises risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Maximum age: 75 (raises risk) · Who can join
• Trials the sponsor started in the prior 2 years: 55 (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Keywords listed: 1 (raises risk) · Design
• Blinding: quadruple (lowers risk) · Design
• Number of arms: 4 (lowers risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports before start: 3102 (raises risk) · Drug's FDA history

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 in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder NCT01467700 · started 2011 · scored riskier than 40% of active trials terminated
• Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder NCT01677182 · started 2012 · scored riskier than 71% of active trials terminated
• Efficacy of Lu AA21004 on Cognitive Dysfunction in Major Depressive Disorder NCT01564862 · started 2012 · scored riskier than 57% of active trials completed
• A Phase 3 Study of Lu AA21004 in Patients With Major Depressive Disorder NCT02389816 · started 2015 · scored riskier than 35% of active trials completed
• Zelquistinel in the Treatment of Major Depressive Disorder NCT03586427 · started 2018 · scored riskier than 21% 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.