A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1)
Model scores of the 29,894 trials active now.
Model score 21% for any early termination, 7% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-08-21, after 2018-11-21 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 2020-08-21. 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: msplaceboseverebaselinesyndrome
Phrases that lowered it: participantclinical trialdisorderdsmdrug -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 18.2% (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 51.7% (raises risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
-
Phase: 3 (lowers risk) · Design
-
Blinding: triple (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 98.2% (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Sponsor's past trials: 11 (lowers risk) · Sponsor's track record
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Collaborators: 0 (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
- 3 (typical: 2)
- Number of arms
- 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
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (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
- 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
- 449 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 108 (typical: 412.5)
- Drug's FAERS reports marked serious
- 98.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 51.7% (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
- A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2) NCT04077437 · started 2020 · scored riskier than 75% of active trials completed
- Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD NCT03282123 · started 2017 · scored riskier than 63% of active trials completed
- Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD (Canada) NCT03485287 · started 2018 · scored riskier than 63% 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
- Randomized, Double-blind, Placebo-Controlled Pilot Study of MDMA-assisted Therapy for PTSD NCT01689740 · started 2013 · scored riskier than 71% 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.