Sodium Benzoate and/or N-Acetylcysteine Added to TAU in Patients With Early Schizophrenia Spectrum Disorder.
Model scores of the 29,894 trials active now.
Model score 7% 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 11% of the time (407 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-03-30, after 2019-01-01 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2021-03-30. 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.
What moved the score
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Primary purpose: other (lowers risk) · Design
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Design: factorial (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: breastdetermineearlyplacebo controlledpast
Phrases that lowered it: relevantbetween 18maleagedinvestigator -
Phase: 2 (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 52.6% (lowers risk) · Drug's FDA history
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Number of arms: 4 (lowers risk) · Design
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Drug's FAERS reports with a death: 6.3% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports in the prior 12 months: 5787 (raises risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Sponsor's past trials: 16 (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Keywords listed: 7 (lowers risk) · Design
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
- 4 (typical: 2)
- Allocation
- randomized
- Design
- factorial (typical: parallel)
- Primary purpose
- other (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 7 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 35 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 16 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 7 (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
- 43435 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5787 (typical: 412.5)
- Drug's FAERS reports marked serious
- 52.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- acetylcysteine, benzoate
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
- A Phase 2 Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia NCT01678755 · started 2012 · scored riskier than 20% of active trials completed
- A Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia NCT01655680 · started 2012 · scored riskier than 21% of active trials completed
- Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia NCT02832037 · started 2016 · scored riskier than 30% of active trials completed
- Efficacy and Safety Study for Cognitive Deficits in Adult Subjects With Schizophrenia NCT01077700 · started 2010 · scored riskier than 27% of active trials completed
- Randomized Double Blind Placebo Control Study in Patients with Schizophrenia NCT01602029 · started 2010 · scored riskier than 14% 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.