False · Brier 0.49
Rules 1.1.0 · as of 14 Sep 2026
Rick Doblin · Said 12 Dec 2022 · doblin-0180
Quote
“I think we're gonna have a good safety profile and I think we'll have statistical significance, but that remains to be seen and we'll know before the end of the year.”
Doblin on The Third Wave episode 173 expects the second MDMA Phase 3 study to show a good safety profile and statistical significance, with results known before the end of 2022.
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 ›
- MAPP2 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 ›
- 31 Dec 2022 AnchorThe fixed table that turns the person's own words ('by 2026', 'Q2', 'within two years') into a deadline. The coder never invents a date. Method › · “before the end of the year”
- Probability
- 0.70 LexiconThe fixed five-bin table that turns a phrase into a probability. The strongest phrase in the claim sentence decides; coders never read tone. Method › · binOne of five lexicon steps: A 'will' 0.90, B 'probably' 0.70, C 'may' 0.50, D 'unlikely' 0.30, E 'never' 0.10. A stated number goes to the nearest bin for calibration only. Method › B · “I think we'll have statistical significance”
- 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
- 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-0009 · deadline 31 Dec 2022 · bin B
Registry entry
MAPP2 (NCT04077437), the second 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 MAPP2 (NCT04077437), the second 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 NCT04077437 (results section), with the sponsor's topline press release or the first publication fixing the date.
Resolution source: ClinicalTrials.gov record NCT04077437 (results); sponsor topline press release or first publication as the secondary source
Readings: 'the second phase three study looks good' reads as MAPP2 meeting its prespecified primary endpoint with statistical significance.
How to read
Coder C
Resolution
- State
- False
- 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 ›
- 31 Dec 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 5 Jan 2023 · checked through 13 Sep 2026
- Resolver note
- Criterion: the first of the sponsor topline release, the CT.gov results posting or the publication that reports the prespecified primary endpoint (CAPS-5 change vs placebo with therapy) met with statistical significance. The sponsor release of 2023-01-05 states that MAPP2 (NCT04077437; 104 randomized) 'met both the primary endpoint as measured by the change from baseline in CAPS-5' and the key secondary SDS endpoint; it gives no p-value. Significance is confirmed by the peer-reviewed report (Nature Medicine, 2023-09-14: LS mean CAPS-5 change -23.7 vs -14.8, P<0.001, d=0.7) and by the CT.gov results section (first posted 2023-10-11). Date fixed at the topline release, the earliest of the three. The 2024 CRL and the 2026 NDA resubmission concern approval, not this trial-result event.
- Evidence
- MAPS PBC Announces Positive Results from Confirmatory Phase 3 "MAPP2" Trial of MDMA-Assisted Therapy for Treatment of PTSD · 5 Jan 2023
- A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2), NCT04077437, results section · 11 Oct 2023
- MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial (Nature Medicine 29:2473-2480; PMID 37709999) · 14 Sep 2023
- BrierThe squared gap between a probability and the outcome, (p - o)^2. 0 is perfect, 0.25 is the constant coin flip, 1 is confidently wrong. Lower is better. Method ›
- 0.49 = (0.70 − 0)²
- Happened laterFor items scored false whose event later happened: the months between the deadline and the outcome date. Median and quartiles are reported. Method ›
- Yes, 1 month after the deadline
Adversarial recheck
upheld (evidence): The 2023-01-05 release (PR Newswire and mapsbcorp.com) says MAPP2 'met both the primary endpoint as measured by the change from baseline in CAPS-5 and the key secondary endpoint', but it gives no p-value and never says 'statistically significant'; the parent MAPS post of the same day gives no efficacy statistic at all. One could push the date to the Nature Medicine paper (2023-09-14, P<0.001) or the ClinicalTrials.gov results posting (2023-10-11). I do not: a sponsor's statement that a trial 'met' its prespecified primary endpoint is the standard report that the prespecified test reached significance, the publication confirmed it, and the criterion accepts significance 'as reported by the sponsor'. No earlier disclosure exists; the 2022-11-17 completion release only promised topline results in Q1 2023. Occurred on 2023-01-05 stands.
How to read
Registry
Timeline
1 claim against 39 events in the field.
Trial outcomes