Pharmacokinetics and Tolerability Study of Risperidone ISM® in Schizophrenia
Model scores of the 29,894 trials active now.
Model score 9% 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 16% of the time (269 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 2015-03-31, after 2014-03-31 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 2015-03-31. 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) (lowers risk) · Wording
Phrases that raised it: syndromestableuncontrolledin siturisk
Phrases that lowered it: hepatitisreceiptpositiveclinical trialalcohol -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Design: parallel (raises risk) · Design
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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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Has a data monitoring committee: No (lowers risk) · Design
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Maximum age: 65 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 88.9% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Blinding: none (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Keywords listed: 0 (raises risk) · Design
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Number of arms: 2 (raises risk) · Design
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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.
The trial
Design
- Phase
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 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
- 6 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 29752 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3143 (typical: 412.5)
- Drug's FAERS reports marked serious
- 88.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- risperidone
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
- Pharmacokinetic, Safety, and Tolerability Study of Risperidone ISM® at Different Dose Strengths NCT01788774 · started 2013 · scored riskier than 11% of active trials completed
- Characterization of Intramuscular Injections of Risperidone 4 Week Long-acting Injectable (LAI) Formulation in the Buttock of Patients With Schizophrenia NCT00821600 · started 2008 · scored riskier than 8% of active trials completed
- Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With Schizophrenia NCT06276361 · started 2023 · scored riskier than 8% of active trials completed
- Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia NCT00731549 · started 2008 · scored riskier than 20% of active trials completed
- Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia NCT00705783 · started 2008 · 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.