Naltrexone Plus Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder
Model scores of the 29,894 trials active now.
Model score 8% 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 8% of the time (37 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-06-30, after 2016-05-31 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 2018-06-30. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: priorwomeneffectiveinfusiondefined
Phrases that lowered it: alcoholdisorderdsmevaluatedrinking -
Sponsor's past termination rate: 18.2% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
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Minimum age: 21 (lowers risk) · Who can join
-
Has a data monitoring committee: not given (lowers risk) · Design
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Drug's FAERS reports marked serious: 48.2% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 8.3% (lowers risk) · Drug's FDA history
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Design: single group (raises 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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Responsible party: principal investigator (lowers risk) · Design
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Sponsor's past trials: 11 (lowers risk) · Sponsor's track record
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Number of arms: 1 (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Blinding: none (raises 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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- 65 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 11 (typical: 32)
- Sponsor's past termination rate
- 18.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (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
- 7931 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3971 (typical: 412.5)
- Drug's FAERS reports marked serious
- 48.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- ketamine, 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
- Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder NCT02461927 · started 2015 · scored riskier than 11% of active trials completed
- Ketamine for Depression and Alcohol Dependence NCT01551329 · started 2012 · scored riskier than 16% of active trials completed
- Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse NCT03539887 · started 2018 · scored riskier than 11% of active trials completed
- Ketamine for the Treatment of Opioid Use Disorder and Depression NCT04177706 · started 2020 · scored riskier than 77% of active trials completed
- KAP for Depression in Abstinent Opioid Users NCT05193318 · started 2022 · scored riskier than 50% of active trials terminated
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.