Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Model scores of the 29,894 trials active now.

Model score 15% 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 10% of the time (1,463 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 2013-10-31. 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: patient hasthe patientto determinedepressionpatient must
  Phrases that lowered it: evaluate theto evaluateinvestigatoracidvisit
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 13.0% (raises risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports with a death: 7.6% (lowers risk) · Drug's FDA history
• Has a data monitoring committee: Yes (raises risk) · Design
• Design: single group (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Disease area, cancer: No (lowers risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 15 (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 79.4% (lowers risk) · Drug's FDA history
• Disease area, neurology: No (lowers risk) · Disease area
• Blinding: none (lowers risk) · Design
• Drug's FAERS reports in the prior 12 months: 790 (raises risk) · Drug's FDA history
• Drug's FAERS reports before start: 3576 (raises risk) · Drug's FDA history
• Responsible party: sponsor (lowers risk) · Design
• Sponsor's past trials: 46 (lowers risk) · Sponsor's track record
• Maximum age: 65 (raises risk) · Who can join

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 to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder NCT01305408 · started 2011 · scored riskier than 71% of active trials completed
• Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder NCT01072630 · started 2010 · scored riskier than 71% of active trials completed
• A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder NCT01072929 · started 2010 · scored riskier than 70% of active trials completed
• Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder. NCT00958633 · started 2010 · scored riskier than 18% of active trials terminated
• Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients NCT01567527 · started 2012 · scored riskier than 36% 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.