Midomafetamine HCl

DRUG12 trials

Sponsors

Lykos Therapeutics, MAPS Europe B.V., Resilient Pharmaceuticals

Conditions

AnxietyHealthy VolunteersHepatic ImpairmentPTSDPharmacokineticsPosttraumatic Stress DisorderPsychological Effects of Study DrugSocial Anxiety in Autistic Adults

Phase 1

Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers

CompletedNCT01404754

Lykos TherapeuticsPsychological Effects of Study Drug

Start: 2011-04-09End: 2022-08-05Updated: 2024-10-31

MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function

Not yet recruitingNCT03606538

Lykos TherapeuticsHepatic Impairment, Pharmacokinetics

Start: 2026-03-29End: 2028-12-31Target: 16Updated: 2024-10-30

Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (MT-2)

WithdrawnNCT04073433

Lykos TherapeuticsPsychological Effects of Study Drug

Start: 2024-12-31End: 2025-12-31Updated: 2024-10-31

Study of Midomafetamine in Healthy Adults

RecruitingNCT07584720

Resilient PharmaceuticalsHealthy Volunteers

Start: 2026-04-23End: 2026-07-30Target: 32Updated: 2026-05-13

Phase 2

MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder

CompletedNCT00090064

Lykos TherapeuticsPosttraumatic Stress Disorder

Start: 2004-03-12End: 2010-06-21Updated: 2025-06-06

Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With PTSD

TerminatedNCT01958593

Lykos TherapeuticsPosttraumatic Stress Disorder

Start: 2014-10-14End: 2016-10-17Updated: 2025-06-05

Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults

CompletedNCT02008396

Lykos TherapeuticsSocial Anxiety in Autistic Adults

Start: 2014-04-11End: 2017-04-28Updated: 2025-06-05

MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness

CompletedNCT02427568

Lykos TherapeuticsAnxiety

Start: 2015-05-14End: 2018-05-17Updated: 2025-06-05

Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD (Canada)

CompletedNCT03485287

Lykos TherapeuticsPosttraumatic Stress Disorder

Start: 2018-03-13End: 2019-06-04Updated: 2025-06-10

Open Label Study of MDMA-assisted Psychotherapy for Treatment of PTSD With Optional fMRI Sub-Study

CompletedNCT04030169

MAPS Europe B.V.PTSD

Start: 2020-06-24End: 2023-12-15Updated: 2025-01-28

Phase 3

A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1)

CompletedNCT03537014

Lykos TherapeuticsPosttraumatic Stress Disorder

Start: 2018-11-21End: 2020-08-21Updated: 2025-06-06

A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD

CompletedNCT04714359

Lykos TherapeuticsPTSD

Start: 2021-03-08End: 2023-11-06Updated: 2025-06-06

Related Papers

Effects of MDMA-assisted therapy for PTSD on self-experience

PLoS ONE2024-01-1040 citations

Preliminary evidence for the importance of therapeutic alliance in MDMA-assisted psychotherapy for posttraumatic stress disorder

European journal of psychotraumatology2024-01-0227 citations

MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study

FOCUS The Journal of Lifelong Learning in Psychiatry2023-07-0189 citations

Pilot study suggests DNA methylation of the glucocorticoid receptor gene (NR3C1) is associated with MDMA-assisted therapy treatment response for severe PTSD

Frontiers in Psychiatry2023-02-0625 citations

MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.

2021-05-10521 citations

MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study

Scientific Reports2020-11-24161 citations

RETRACTED ARTICLE: Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials

Psychopharmacology2020-06-04161 citations

Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline.

2019-09-1296 citations

RETRACTED ARTICLE: MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials

Psychopharmacology2019-05-07357 citations

Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study

Psychopharmacology2018-09-08270 citations