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Midomafetamine HCl

DRUG11 trials

Sponsors

Lykos Therapeutics, MAPS Europe B.V.

Conditions

AnxietyHepatic 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

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