True · Brier 0.01
Rules 1.1.0 · as of 14 Sep 2026
Rick Doblin · Said 26 Aug 2020 · doblin-0251
Quote
“what we learned is that we were doing great, that we didn't need to add a single person to the study and that we had a 90% or greater probability of statistical significance once the study was completed, and we had the primary outcome data for all 100”
Doblin reports the MAPP1 interim analysis result and the probability that the full trial reaches statistical significance.
Intake
- EventA proposition written from a template on the asset, with a resolution criterion and a named public source, before the outcome is looked up. The same event resolves every person's items on it. Method ›
- MAPP1 Phase 3 trial of MDMA-assisted therapy for PTSD meets its primary endpoint
- AreaOne of five topic classes: regulatory decisions, clinical trial outcomes, company and market outcomes, payer and policy, practice adoption. Every event has one area. Method ›
- Trial outcomes
- DeadlineThe date by which the event must happen for the item to be true. It comes only from the person's words through the anchor table. Method ›
- None stated · undated panelItems with no deadline in the person's words, scored on a uniform 24-month window from the statement date. Part of the headline panel since rules 1.1.0; also shown on its own. Method ›, 24-month window to 26 Aug 2022
- Probability
- 0.90 Stated · “0.9” · “a 90% or greater probability of statistical significance once the study was completed”
- Base rateThe probability a published external study gives an event of that class and stage, fixed at intake. Halved when the item window is shorter than the class median time to decision. Never learned from the ledger's own items. Method ›
- None in the table
- Tags
- stated_number, affiliated, retrospective
- Coder BCohen's kappa: agreement between two coders beyond chance, from -1 to 1. Reported for admit, event, deadline, bin and asserts from the second-coder match test. Method ›
- admittedA statement that passed intake: sincere, the person's own claim, forward-looking, inside the five areas, and not excluded by a reason code. Only admitted statements become items. Method › · event E-0002 · deadline none · bin –
Registry entry
MAPP1 (NCT03537014), the first Phase 3 trial of MDMA-assisted therapy for PTSD, reports its prespecified primary endpoint met with statistical significance.
TRUE on the date of the sponsor's topline release, the ClinicalTrials.gov results posting or the peer-reviewed publication that first reports that MAPP1 (NCT03537014), the first Phase 3 trial of MDMA-assisted therapy for PTSD, met its prespecified primary endpoint (change in CAPS-5 total severity score versus placebo with therapy) with statistical significance as reported by the sponsor. FALSE on the date the sponsor first reports that the primary endpoint was not met, and FALSE at the deadline when no primary-endpoint result has been reported. Secondary endpoints, interim analyses and pooled analyses do not count. Resolution source: the ClinicalTrials.gov record NCT03537014 (results section), with the sponsor's topline press release or the first publication fixing the date.
Resolution source: ClinicalTrials.gov record NCT03537014 (results); sponsor topline press release or first publication as the secondary source
Readings: 'the study' that 'the other people' are finishing (doblin-0012) and 'Phase 3 results match Phase 2' (doblin-0007) both read as the first Phase 3 trial, MAPP1, meeting its primary endpoint.; Statistical significance is read at the trial's prespecified alpha on the primary endpoint, as reported by the sponsor.
How to read
Coder A
Resolution
- State
- True
- Effective deadlineAn item enters the score only when its deadline has passed and the outcome is true or false. A claim already known true still waits for its deadline. Method ›
- 26 Aug 2022
- Outcome1 if the registry event happened on or before the item's deadline, 0 if it did not. Written by a resolver who never sees p. Method ›
- occurred on 3 May 2021 · checked through 13 Sep 2026
- Resolver note
- Occurred. The sponsor's topline release of 2021-05-03 first reported that MAPP1 (NCT03537014, 90 participants) met its prespecified primary endpoint: MDMA-assisted therapy gave a significant reduction in CAPS-5 total severity versus placebo with therapy (p<0.0001). The peer-reviewed publication followed in Nature Medicine on 2021-05-10 (d=0.91, P<0.0001), and ClinicalTrials.gov posted results on 2021-09-16 (CAPS-5 change -24.5 vs -12.64). The 2020 interim analysis is excluded by the criterion, so the date is the earliest of the three named sources, the sponsor release.
- Evidence
- MAPS' Phase 3 Trial of MDMA-Assisted Therapy for PTSD Achieves Successful Results for Patients with Severe, Chronic PTSD · 3 May 2021
- A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1), NCT03537014, results section · 16 Sep 2021
- MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study · 10 May 2021
- PubMed record 33972795 (Nature Medicine, electronic publication 2021-05-10; NCT03537014) · 10 May 2021
Adversarial recheck
upheld (date): I tried to move the date. The 2020 interim analysis is excluded by the criterion. MAPS's release of 2021-05-03 reports a significant reduction on the primary PTSD-severity measure versus placebo with therapy (p<0.0001); Nature Medicine published the paper on 2021-05-10; ClinicalTrials.gov results were first submitted 2021-08-18 and posted 2021-09-16. I found no earlier public report: MAPS's own 2021-05-21 summary says the results were announced May 3 and published May 10. The release came from MAPS, the parent of sponsor MAPS PBC, which the criterion accepts as the sponsor's topline release. Occurred on 2021-05-03 stands.
How to read
Registry
Receding horizon
Doblin promised MAPP1 Phase 3 trial of MDMA-assisted therapy for PTSD meets its primary endpoint 2 times; it happened on 3 May 2021.
Cluster E-0002
Timeline
1 claim against 44 events in the field.
Trial outcomes