Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

Model scores of the 29,894 trials active now.

Model score 15% for any early termination, 4% 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 2013-04-01. 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
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: subject hassymptomsstableto determinepurpose of
  Phrases that lowered it: days30productsopen labelabuse
• Drug's FAERS reports marked serious: 33.6% (lowers risk) · Drug's FDA history
• Has a data monitoring committee: Yes (raises risk) · Design
• Sponsor's past termination rate: 8.3% (raises risk) · Sponsor's track record
• Design: single group (raises risk) · Design
• Phase: 3 (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports with a death: 1.5% (lowers risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Trials the sponsor started in the prior 2 years: 58 (lowers risk) · Sponsor's track record
• Disease area, psychiatry: Yes (raises risk) · Disease area
• Sponsor's past trials: 144 (lowers risk) · Sponsor's track record
• Maximum age: 65 (raises risk) · Who can join
• Drug's FAERS reports before start: 3730 (raises risk) · Drug's FDA history
• Keywords listed: 1 (raises risk) · Design
• Drug's FAERS reports in the prior 12 months: 419 (raises risk) · Drug's FDA history
• Disease area, neurology: No (lowers risk) · Disease area

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.

• SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia NCT01760889 · started 2013 · scored riskier than 66% of active trials terminated
• Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia NCT01738698 · started 2012 · scored riskier than 77% of active trials terminated
• Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms NCT00922272 · started 2009 · scored riskier than 34% of active trials completed
• A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan NCT05359081 · started 2022 · scored riskier than 39% of active trials terminated
• Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238) NCT01244828 · started 2011 · scored riskier than 17% 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.