MDMA-Assisted Therapy for Major Depressive Disorder: A Seven-Month Follow-Up Proof of Principle Trial
This long-term follow-up (n=12) of participants with moderate-to-severe major depressive disorder who received MDMA-assisted therapy (two dosing sessions integrated with nine psychotherapy sessions) found significant reductions in depression severity and functional impairment at seven months compared to baseline, with improvements maintained from the post-treatment assessment and no increases in suicidal ideation.
Authors
- Kvam, T. M.
- Goksøyr, I. W.
- Rog, J.
Published
Abstract
Background
Major depressive disorder (MDD) is a leading cause of global disability, and current treatments often fail to provide sustained effectiveness. MDMA-assisted therapy (MDMA-AT) is a promising treatment for MDD. However, the long-term effects are not known.
Objectives
To examine the long-term effects of MDMA-AT for MDD.
Methods
Twelve participants with MDD and an ongoing moderate to severe depressive episode received MDMA-AT in two MDMA dosing sessions one month apart, integrated with nine psychotherapy sessions. Clinical assessments were done before MDMA-AT (baseline), after the final psychotherapy session (post-treatment), and at follow-up seven months after baseline. The primary and secondary outcome measures were the Montgomery-Asberg Depression Rating Scale (MADRS) and Sheehan Disability Scale (SDS), respectively. Suicidality was tracked with the Columbia-Suicide Severity Rating Scale. Exploratory outcomes included self-reported assessments of functional impairment, depression, generalized anxiety, insomnia, and PTSD symptoms. We used a mixed-effects model and multinomial logistic regression for analysis of repeated measures.
Results
All twelve participants attended the follow-up visit. At follow-up, there was a significant reduction of MADRS (p < 0.001) and SDS (p = 0.001) scores compared with baseline, along with significant improvements in all exploratory outcome measures. There were no significant changes in any measures from the post-treatment visit. Neither the mean suicidal ideation (SI) score nor the SI intensity rating exceeded pre-study levels.
Conclusion
This long-term follow-up study of MDMA-AT provides preliminary evidence supporting sustained treatment effects and long-term safety in MDD. However, further validation in larger, controlled trials is needed.
Research Summary of 'MDMA-Assisted Therapy for Major Depressive Disorder: A Seven-Month Follow-Up Proof of Principle Trial'
Introduction
Major depressive disorder (MDD) is a common, recurrent and disabling illness for which many patients do not achieve sustained benefit from existing pharmacological and psychological treatments. The authors note high non-response and relapse rates in routine care and trials, and discuss MDMA-assisted therapy (MDMA-AT) as a candidate intervention whose subjective effects (for example, increased self-compassion and emotional processing) may be favourable for psychotherapeutic work. Although pooled long-term data from Phase II MDMA-AT studies for PTSD suggest durable effects, the long-term course of outcomes after MDMA-AT in people with MDD remained uncertain. The present study aimed to provide preliminary long-term follow-up data on safety, retention and sustained efficacy of MDMA-AT in people with moderate to severe MDD. Specifically, the researchers assessed clinical and self-reported outcomes at baseline, after a short treatment course (two MDMA dosing sessions plus preparatory/integration psychotherapy) and at a single follow-up visit seven months after baseline (approximately six months after the final MDMA session and four months after end of treatment). This proof-of-principle study sought to test whether improvements observed shortly after treatment were maintained at that follow-up point.
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Study Details
- Study Typeindividual
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References (11)
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