MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic PTSD
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 21% of the time (1,462 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-05-29, after 2016-07-03 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 2018-05-29. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 25% (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 62.7% (raises risk) · Drug's FDA history
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Phase: 1/2 (raises risk) · Design
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Design: single group (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 98.4% (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Sponsor's past trials: 4 (lowers risk) · Sponsor's track record
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Number of arms: 1 (raises risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: therapychronicpaineffectiveevidence
Phrases that lowered it: participantparticipantsopen labelclinicalthe study -
Collaborators: 0 (raises risk) · Design
-
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
- 1/2 (typical: 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
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 4 (typical: 32)
- Sponsor's past termination rate
- 25% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (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
- 255 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 21 (typical: 412.5)
- Drug's FAERS reports marked serious
- 98.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 62.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- methylenedioxymethamphetamine, midomafetamine
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 Comparing Three Doses of MDMA Along With Therapy in Veterans With Posttraumatic Stress Disorder NCT01211405 · started 2010 · scored riskier than 60% of active trials completed
- Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD NCT01793610 · started 2013 · scored riskier than 70% of active trials completed
- A Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD) NCT05067244 · started 2021 · scored riskier than 45% of active trials completed
- Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial NCT01458327 · started 2010 · scored riskier than 58% of active trials completed
- Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With PTSD NCT01958593 · started 2014 · scored riskier than 32% 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.