A Study to Determine the Maximum Tolerated Dose of an Investigational Drug in Subjects With Schizophrenia
Model scores of the 29,894 trials active now.
Model score 8% 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 7% of the time (289 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2019-03-29, after 2018-06-07 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 2019-03-29. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: subject haspriorsubjects withcarcinomaascending
Phrases that lowered it: dayperiodbloodmmhg28 -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
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Drug's FAERS reports marked serious: 48.8% (lowers risk) · Drug's FDA history
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Sponsor's past termination rate: 5% (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 5.2% (lowers risk) · Drug's FDA history
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Blinding: triple (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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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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Trials the sponsor started in the prior 2 years: 17 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 120 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Maximum age: 65 (raises risk) · Who can join
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Keywords listed: 1 (raises risk) · Design
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Responsible party: sponsor (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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- 65 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 120 (typical: 32)
- Sponsor's past termination rate
- 5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 17 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 6930 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3302 (typical: 412.5)
- Drug's FAERS reports marked serious
- 48.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- lurasidone
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
- Pediatric Schizophrenia Efficacy and Safety Study NCT01911429 · started 2013 · scored riskier than 11% of active trials completed
- Lurasidone Pediatric Pharmacokinetics Study NCT01620060 · started 2012 · scored riskier than 11% of active trials completed
- A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With Schizophrenia NCT02969382 · started 2016 · scored riskier than 45% of active trials completed
- Lurasidone Low-Dose - High-Dose Study Study NCT01821378 · started 2013 · scored riskier than 24% of active trials completed
- PEARL Schizophrenia Maintenance NCT01435928 · started 2011 · scored riskier than 51% 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.