Abstract
RationaleMDMA-assisted psychotherapy is under investigation as a novel treatment for posttraumatic stress disorder (PTSD). The primary mechanism of action of MDMA involves the same reuptake transporters targeted by antidepressant medications commonly prescribed for PTSD.ObjectivesData were pooled from four phase 2 trials of MDMA-assisted psychotherapy. To explore the effect of tapering antidepressant medications, participants who had been randomized to receive active doses of MDMA (75–125 mg) were divided into two groups (taper group (n = 16) or non-taper group (n = 34)).MethodsBetween-group comparisons were made for PTSD and depression symptom severity at the baseline and the primary endpoint, and for peak vital signs across two MDMA sessions.ResultsDemographics, baseline PTSD, and depression severity were similar between the taper and non-taper groups. At the primary endpoint, the non-taper group (mean = 45.7, SD = 27.17) had a significantly (p = 0.009) lower CAPS-IV total scores compared to the taper group (mean = 70.3, SD = 33.60). More participants in the non-taper group (63.6%) no longer met PTSD criteria at the primary endpoint than those in the taper group (25.0%). The non-taper group (mean = 12.7, SD = 10.17) had lower depression symptom severity scores (p = 0.010) compared to the taper group (mean = 22.6, SD = 16.69). There were significant differences between groups in peak systolic blood pressure (p = 0.043) and diastolic blood pressure (p = 0.032).ConclusionsRecent exposure to antidepressant drugs that target reuptake transporters may reduce treatment response to MDMA-assisted psychotherapy.
Highlights
posttraumatic stress disorder (PTSD) is a relatively prevalent disorder, affecting 3 to 4% of the global population (Hoge et al 2004; Koenen et al 2017)
Since the aim of this paper is to evaluate the effect of having recently tapered off reuptake inhibitors on the treatment response, only data from participants who received active MDMA doses in the blinded study segment are included in this analysis
Of the 50 participants randomized to active MDMA doses (75–125 mg), 16 met criteria for the taper group, and the other 34 for the non-taper group (Table 2)
Summary
PTSD is a relatively prevalent disorder, affecting 3 to 4% of the global population (Hoge et al 2004; Koenen et al 2017). Six phase 2 randomized, double-blind placebo-controlled clinical trials were conducted to investigate MDMA-assisted psychotherapy for PTSD treatment (Mithoefer et al 2019; Mithoefer et al 2018; Mithoefer et al 2011; Oehen et al 2013; Ot’alora et al 2018). In these studies, participants worked with a male and female co-therapy team who followed a manualized format of MDMA-assisted psychotherapy. The manualized treatment includes a course of preparatory psychotherapy, two to three 8-hour long MDMA sessions, and follow-up integrative psychotherapy.
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