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Introduction <p>MDMA-assisted psychotherapy (MDMA-AP) is an emerging treatment for post-traumatic stress disorder (PTSD). While early trials show promise, concerns persist around trial design, placebo selection, and sponsorship bias. This systematic review and meta-analysis aimed to evaluate both the efficacy and the certainty of evidence from randomized controlled trials (RCTs)</p> Methods <p>We included six RCTs (280 participants). Due to variability in study design—particularly in the type of placebo (inactive vs. active), dosing frequency, and blinding quality—two separate meta-analyses were conducted. One subgroup included studies using three MDMA sessions with an inactive placebo; the other included two MDMA sessions with an active placebo. The risk of bias was assessed using the Cochrane RoB 2 tool, and the certainty of evidence was rated using the GRADE approach.</p> Results <p>In studies using three MDMA sessions and an inactive placebo, MDMA led to moderate PTSD symptom reduction (MD = −8.75 CAPS points, 95% CI −12.57 to −4.93) and increased remission (OR = 3.29, 95% CI 1.75 to 6.19) with high-certainty evidence. In contrast, studies using two sessions and active placebo showed a larger reduction in symptoms (MD = −22.9, 95% CI −54.1 to 8.4) and higher odds of remission (OR = 3.52, 95% CI 0.68 to 18.37), but with low certainty due to serious imprecision and inconsistency. No long-term blinded outcome data were available. All trials were conducted and funded by a single sponsor.</p> Conclusion <p>While short-term effects of MDMA-AP appear consistent, the strength of evidence varies substantially by trial design. Our findings highlight the need for improved trial standardization, transparent reporting, independent replication, and long-term follow-up before MDMA-AP can be reliably integrated into clinical practice.</p>

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MDMA-Assisted Psychotherapy for PTSD: Evidence Synthesis and Methodological Challenges in a Rapidly Evolving Field

  • 期刊论文

  • 发表日期：

    2025年10月25日

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  • Marija Franka Žuljević,
  • Marin Viđak,
  • Jakša Vukojević,
  • Darko Hren,
  • Tina Poklepović Peričić

摘要

Introduction

MDMA-assisted psychotherapy (MDMA-AP) is an emerging treatment for post-traumatic stress disorder (PTSD). While early trials show promise, concerns persist around trial design, placebo selection, and sponsorship bias. This systematic review and meta-analysis aimed to evaluate both the efficacy and the certainty of evidence from randomized controlled trials (RCTs)

Methods

We included six RCTs (280 participants). Due to variability in study design—particularly in the type of placebo (inactive vs. active), dosing frequency, and blinding quality—two separate meta-analyses were conducted. One subgroup included studies using three MDMA sessions with an inactive placebo; the other included two MDMA sessions with an active placebo. The risk of bias was assessed using the Cochrane RoB 2 tool, and the certainty of evidence was rated using the GRADE approach.

Results

In studies using three MDMA sessions and an inactive placebo, MDMA led to moderate PTSD symptom reduction (MD = −8.75 CAPS points, 95% CI −12.57 to −4.93) and increased remission (OR = 3.29, 95% CI 1.75 to 6.19) with high-certainty evidence. In contrast, studies using two sessions and active placebo showed a larger reduction in symptoms (MD = −22.9, 95% CI −54.1 to 8.4) and higher odds of remission (OR = 3.52, 95% CI 0.68 to 18.37), but with low certainty due to serious imprecision and inconsistency. No long-term blinded outcome data were available. All trials were conducted and funded by a single sponsor.

Conclusion

While short-term effects of MDMA-AP appear consistent, the strength of evidence varies substantially by trial design. Our findings highlight the need for improved trial standardization, transparent reporting, independent replication, and long-term follow-up before MDMA-AP can be reliably integrated into clinical practice.