Abstract
BackgroundPosttraumatic stress disorder is a prevalent mental health condition with substantial impact on daily functioning that lacks sufficient treatment options. Here we evaluate six phase 2 trials in a pooled analysis to determine the study design for phase 3 trials of MDMA-assisted psychotherapy for PTSD.MethodsSix randomized, double-blind, controlled clinical trials at five study sites were conducted from April 2004 to February 2017. Active doses of MDMA (75–125 mg, n = 72) or placebo/control doses (0–40 mg, n = 31) were administered to individuals with PTSD during manualized psychotherapy sessions in two or three 8-h sessions spaced a month apart. Three non-drug 90-min therapy sessions preceded the first MDMA exposure, and three to four followed each experimental session.ResultsAfter two blinded experimental sessions, the active group had significantly greater reductions in CAPS-IV total scores from baseline than the control group [MMRM estimated mean difference (SE) between groups − 22.0 (5.17), P < 0.001]. The between-group Cohen’s d effect size was 0.8, indicating a large treatment effect. After two experimental sessions, more participants in the active group (54.2%) did not meet CAPS-IV PTSD diagnostic criteria than the control group (22.6%). Depression symptom improvement on the BDI-II was greatest for the active group compared to the control group, although only trended towards significant group differences [MMRM, estimated mean difference (SE) between groups − 6.0 (3.03), P = 0.053]. All doses of MDMA were well tolerated, with some expected reactions occurring at greater frequency for the active MDMA group during experimental sessions and the 7 days following.ConclusionsMDMA-assisted psychotherapy was efficacious and well tolerated in a large sample of adults with PTSD. These studies supported expansion into phase 3 trials and led to FDA granting Breakthrough Therapy designation for this promising treatment.Trial registrationClinicalTrials.gov Identifier: NCT00090064, NCT00353938, NCT01958593, NCT01211405, NCT01689740, NCT01793610.
Highlights
Posttraumatic stress disorder (PTSD) is a serious debilitating disorder with lifetime prevalence estimated at nearly 4% globally and over 8% in the USA (Kilpatrick et al 2013; Koenen et al 2017)
Individuals with PTSD may experience a substantial reduction in quality of life and relationships, and the disability resulting from PTSD can have further negative consequences such as obesity (Scott et al 2008), hypertension (Kibler et al 2009), comorbid mental health conditions, and suicidality (Dorrington et al 2014; Tarrier and Gregg 2004)
The aim of this paper is to present pooled data from randomized clinical trials at different study sites that evaluated the efficacy and safety profile of MDMA-assisted psychotherapy among individuals with PTSD from a range of causes
Summary
Posttraumatic stress disorder (PTSD) is a serious debilitating disorder with lifetime prevalence estimated at nearly 4% globally and over 8% in the USA (Kilpatrick et al 2013; Koenen et al 2017). Individuals with PTSD may experience a substantial reduction in quality of life and relationships, and the disability resulting from PTSD can have further negative consequences such as obesity (Scott et al 2008), hypertension (Kibler et al 2009), comorbid mental health conditions, and suicidality (Dorrington et al 2014; Tarrier and Gregg 2004). In addition to these profound costs to individuals with PTSD, the disorder exerts a substantial economic toll through lost productivity and treatment costs (Marshall et al 2000). Three non-drug 90-min therapy sessions preceded the first MDMA exposure, and three to four followed each experimental session
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