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

NCT04030169 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MP18
• Study Type: interventional
• Target: 21
• Locations: 5 countries
• Sites: 6

Brief Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people diagnosed with at least severe PTSD. The main question it aims to answer is: Do two open-label sessions of MDMA-assisted therapy reduce PTSD symptoms? Participants will receive three non-drug preparatory sessions followed by two sessions of MDMA-assisted therapy. Each MDMA-assisted therapy session is followed by three non-drug integrative therapy sessions.

Conditions

PTSD

Keywords

MDMA; methylenedioxymethamphetamine; psychotherapy; PTSD; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Change in CAPS-5 Total Severity Score

  The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 30-item semi-structured interview assessing PTSD in the past month through diagnostic and symptom severity scores anchored to a DSM-5 defined traumatic event. The CAPS-5 produces a Total Severity Score based on severity of PTSD domains described in the DSM-5, as well as a categorical rating indicating whether a participant meets PTSD diagnostic criteria. CAPS-5 Total Symptom Severity scores range from 0 to 80 with higher values designating greater symptom severity. CAPS-5 assigns PTSD diagnosis as being present or absent.

  13 weeks post-baseline

Secondary Outcomes (1)

• Change in Sheehan Disability Scale (SDS) Item Scores

  13 weeks post-baseline

Study Arms (1)

Experimental: MDMA-assisted psychotherapy

EXPERIMENTAL

Administration of 80 to 120 mg midomafetamine (MDMA) HCl followed by a supplemental half-dose 1.5 to 2 hrs after the initial dose of 40 or 60 mg, respectively, in combination with manualized psychotherapy.

Drug: Midomafetamine HCl

Interventions

Midomafetamine HCl DRUG

Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session

Also known as: 3,4-methylenedioxymethamphetamine, MDMA, MDMA HCl, Midomafetamine

Experimental: MDMA-assisted psychotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are at least 18 years old
• Are fluent in speaking and reading the predominantly used or recognized language of the study site
• Are able to swallow pills
• Agree to have study visits video-recorded, including Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions
• Must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable
• Must agree to inform the investigators within 48 hours of any medical treatments and procedures
• People able to become pregnant (PABP) (i.e., assigned female at birth, fertile, following menarche and until becoming post-menopausal unless permanently sterile), must have a highly sensitive negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session. Adequate birth control methods include intrauterine device (IUD), injected or implanted hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner.
• Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not enroll in any other interventional clinical trials during the duration of the study, remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures

You may not qualify if:

• Are not able to give adequate informed consent
• Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation
• Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist
• Require ongoing concomitant therapy with a psychiatric medication (exceptions apply)
• Weigh less than 48 kilograms (kg)
• Are pregnant or nursing or are able to become pregnant and are not practicing an effective means of birth control.
• Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure (BP) and heart rate.
• Have current alcohol or substance use disorder.
• Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the first Experimental Session; or have previously participated in a clinical trial conducted by the sponsor.

Sponsors & Collaborators

• MAPS Europe B.V.: lead
• Multidisciplinary Association for Psychedelic Studies: collaborator

Study Sites (6)

NUDZ - National Institute of Mental Health

Klecany, Central Bohemia, 250 67, Czechia

Location

Charité - Universitätsmedizin, Berlin Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Stichting Centrum '45/Arq

Oegstgeest, Noord Holand, 2342 AX, Netherlands

Location

Sykehuset Østfold Hf, DPS Norder

Moss, 1535, Norway

Location

University Hospital of Wales - Research Facility

Cardiff, CF14 4XW, United Kingdom

Location

The Institute of Psychiatry, Psychology and Neuroscience

London, SE5 8AF, United Kingdom

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Berra Yazar-Klosinski, PhD / Chief Scientific Officer
• Organization: Lykos Therapeutics

trialdata@lykospbc.com

877-627-7722

Study Officials

• Prof. Dr. Eric Vermetten, MD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This study will be open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Examining safety and effects of two sessions of MDMA-assisted psychotherapy, with Clinician-Administered PTSD Scale for DSM 5 (CAPS-5) severity after treatment compared with baseline

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 23, 2019
• Study Start: June 24, 2020
• Primary Completion: December 14, 2023
• Study Completion: December 15, 2023
• Last Updated: January 28, 2025
• Results First Posted: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data and study-related documents will be available when all participants have completed the study.
• Access Criteria: Interested persons should correspond with the central contact for the multi-site study.

Locations

DE (1); NL (1); NO (1); CZ (1); GB (2)