Lykos Therapeutics

A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2)

Start Date

August 27, 2020

Compounds

MDMA, Placebo

Randomized, Double-blind, Active Placebo-Controlled Pilot Study of MDMA-assisted Psychotherapy in People With Chronic PTSD

Start Date

January 3, 2013

Compounds

MDMA

MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial

This multi-site, randomised, double-blind, Phase IIIb trial (n=104) evaluated the efficacy and safety of MDMA-assisted therapy (MDMA-AT) for individuals with moderate to severe PTSD. The study found significant reductions in PTSD severity (CAPS-5 score) and functional impairment (SDS score) for the MDMA-AT group compared to placebo with therapy. Seven participants experienced severe treatment-emergent adverse events, but no deaths or serious adverse events were reported. The treatment was found to be generally well tolerated in a diverse population.

Published

September 14, 2023

Journal

Nature Medicine

Authors

Balliett, B., Bogenschutz, M. P., de Boer, A., Doblin, R., Gelfand, Y., Hamilton, S., Harrison, C., Kleiman, S., Mitchell, J., Mithoefer, A. T., Nicholas, C. R., Ot’alora G, M., Paleos, C., Parker-Guilbert, K., Quevedo, S., Shannon, S., Tzarfaty, K., van der Kolk, B., Yazar-Klosinski, B.

Long-term Follow-Up Outcomes of MDMA-assisted Psychotherapy for Treatment of PTSD: A Longitudinal Pooled Analysis of Six Phase 2 Trials

This long-term follow-up study (n=107) examines the effects of MDMA-assisted psychotherapy on PTSD symptoms. It finds a significant reduction in PTSD symptoms both at treatment exit and at least 12 months post-treatment, with 67% of participants no longer meeting PTSD criteria at long-term follow-up.

Published

June 4, 2020

Journal

Journal of Psychopharmacology

Authors

Doblin, R., Emerson, A., Feduccia, A. A., Hamilton, S., Jerome, L., Mithoefer, M. C., Wang, J. B., Yazar-Klosinski, B.

Breakthrough for trauma treatment: safety and efficacy of MDMA-assisted psychotherapy compared to paroxetine and sertraline

This review (2019) details the potential superiority of MDMA-assisted psychotherapy as a treatment for PTSD compared to the conventional treatment options paroxetine and sertraline.

Published

September 12, 2019

Journal

Frontiers in Psychiatry

Authors

Doblin, R., Emerson, A., Feduccia, A. A., Jerome, L., Mithoefer, M. C., Yazar-Klosinski, B.