Naltrexone SR and Fluoxetine Combination Therapy in Subjects With Obsessive-Compulsive Disorder
Model scores of the 29,894 trials active now.
Model score 9% for any early termination, 3% 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
Terminated on 2008-12-31, after 2008-09-30 start.
Reason given by the sponsor: “business”
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 2008-12-31. 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) (lowers risk) · Wording
Phrases that raised it: diagnosistherapysyndrometo determineinvestigators
Phrases that lowered it: malesubjectssubjectscreeningcaffeine -
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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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports with a death: 11.6% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 3 (lowers risk) · Design
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Sponsor's past trials: 2 (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 7 (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports before start: 12333 (raises risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 79.7% (lowers risk) · Drug's FDA history
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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 60 (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
- 2 (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
- 12333 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2661 (typical: 412.5)
- Drug's FAERS reports marked serious
- 79.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- fluoxetine, naltrexone
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 to Evaluate the Effect of AFQ056 in Obsessive Compulsive Disorder (OCD) Patients Resistant to Selective Serotonin Reuptake Inhibitor (SSRI) Therapy NCT01813019 · started 2013 · scored riskier than 88% of active trials terminated
- A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder NCT00997087 · started 2009 · scored riskier than 53% of active trials terminated
- Efficacy and Safety Study of Low-Dose Ondansetron For Adjunctive Therapy In Adult Patients With Obsessive-Compulsive Disorder NCT01275248 · started 2011 · scored riskier than 57% of active trials terminated
- Troriluzole (BHV-4157) in Adult Participants With Obsessive Compulsive Disorder NCT03299166 · started 2017 · scored riskier than 51% of active trials completed
- A Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors (SSRIs) in Participants With Obsessive-Compulsive Disorder (OCD) NCT01674361 · started 2012 · scored riskier than 38% 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.