Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD

Model scores of the 29,894 trials active now.

Model score 17% 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 16% of the time (269 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2019-09-30. 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: definedpatientsmonths priordepressionadequate
  Phrases that lowered it: check inthe safetytolerabilityefficacyasthma
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Design: parallel (raises risk) · Design
• Drug's FAERS reports with a death: 38.7% (raises risk) · Drug's FDA history
• Blinding: triple (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Has a data monitoring committee: No (lowers risk) · Design
• Disease area, psychiatry: Yes (raises risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Number of arms: 3 (lowers risk) · Design
• Drug's FAERS reports before start: 27367 (raises risk) · Drug's FDA history
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• 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.

• A Study to Evaluate the Efficacy and Safety of MIN-117 in Adult Patients With Major Depressive Disorder NCT03446846 · started 2018 · scored riskier than 41% of active trials completed
• Zelquistinel in the Treatment of Major Depressive Disorder NCT03586427 · started 2018 · scored riskier than 21% of active trials completed
• A Paroxetine- and Placebo-Controlled Study of 50 mg/Day and 100 mg/Day of EB-1010 Among Outpatients With Major Depressive Disorder Who Have Responded Inadequately to Prior Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) NCT01318434 · started 2011 · scored riskier than 72% of active trials completed
• Trazodone Once a Day in Major Depression Disorder NCT02086929 · started 2012 · scored riskier than 31% of active trials completed
• A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD NCT05414422 · started 2022 · scored riskier than 53% 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.