Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 2% 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.
How it ended
Completed on 2013-12-31, after 2011-07-31 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 2013-12-31. 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
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: dsmschizophreniaivtrto screening
Phrases that lowered it: subjectsdouble blindrandomized doubleperiodsafety -
Sponsor's past termination rate: 3.0% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 53.8% (lowers risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports with a death: 5.5% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
-
Disease area, psychiatry: Yes (raises risk) · Disease area
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Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 24 (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
-
Blinding: triple (raises risk) · Design
-
Drug's FAERS reports before start: 17025 (raises risk) · Drug's FDA history
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Number of arms: 3 (lowers risk) · Design
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Sponsor's past trials: 66 (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
- 3 (typical: 2)
- Number of arms
- 3 (typical: 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
- 2 (typical: 1)
Who can join
- Minimum age
- 13 (typical: 18)
- Maximum age
- 17 (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
- 66 (typical: 32)
- Sponsor's past termination rate
- 3.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 24 (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
- 17025 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2726 (typical: 412.5)
- Drug's FAERS reports marked serious
- 53.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- aripiprazole
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
- Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features. NCT01122927 · started 2010 · scored riskier than 12% of active trials terminated
- Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) in Adolescents With Schizophrenia NCT02411695 · started 2015 · scored riskier than 12% of active trials completed
- A Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder NCT04512066 · started 2020 · scored riskier than 31% of active trials completed
- Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia NCT01663532 · started 2012 · scored riskier than 14% of active trials completed
- Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia NCT00706654 · started 2008 · scored riskier than 24% 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.