Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 8% of the time (37 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.
How it ended
Completed on 2015-12-31, after 2009-12-31 start.
The score above never used this outcome: 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.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2015-12-31. 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.
What moved the score
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: ivbreastinjurydsmschizophrenia
Phrases that lowered it: examinationseizuresphysicalefficacyecg -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Minimum age: 21 (lowers risk) · Who can join
-
Sponsor's past termination rate: 6.2% (lowers risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 50% (lowers risk) · Drug's FDA history
-
Design: parallel (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 62 (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: 7.9% (lowers risk) · Drug's FDA history
-
Blinding: triple (raises risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Number of arms: 2 (raises risk) · Design
-
Sponsor's past trials: 32 (lowers risk) · Sponsor's track record
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.
The trial
Design
- Phase
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- 65 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 32
- Sponsor's past termination rate
- 6.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 62 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 38 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4 (typical: 412.5)
- Drug's FAERS reports marked serious
- 50% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- dietary supplement, pregnenolone
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Study of a Neurocognition Enhancing Agent in Patients With Schizophrenia NCT00894842 · started 2009 · scored riskier than 55% of active trials completed
- Development of Pregnenolone as a Treatment for Depression NCT03645096 · started 2019 · scored riskier than 46% of active trials completed
- Oxytocin as Adjunctive Treatment of Schizophrenia NCT01568528 · started 2013 · scored riskier than 11% of active trials completed
- Efficacy of Cognitive Remediation in Patients With Schizophrenia or Schizoaffective Disorder Stabilized on Lurasidone NCT01173874 · started 2010 · scored riskier than 41% of active trials completed
- Estradiol Patch as add-on to Antipsychotics in Patients With Schizophrenia, Schizoaffective or Schizophreniform Disorder NCT03848234 · started 2015 · scored riskier than 29% 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.