A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2)
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ClinicalTrials.gov Identifier: NCT04077437 |
Recruitment Status :
Completed
First Posted : September 4, 2019
Results First Posted : October 11, 2023
Last Update Posted : January 24, 2024
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | August 30, 2019 | ||||||||||||||
First Posted Date ICMJE | September 4, 2019 | ||||||||||||||
Results First Submitted Date ICMJE | September 19, 2023 | ||||||||||||||
Results First Posted Date ICMJE | October 11, 2023 | ||||||||||||||
Last Update Posted Date | January 24, 2024 | ||||||||||||||
Actual Study Start Date ICMJE | September 2, 2020 | ||||||||||||||
Actual Primary Completion Date | October 30, 2022 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Change From Baseline to Primary Endpoint in Clinician Administered PTSD Scale for DSM-V (CAPS-5) [ Time Frame: Baseline to 18 weeks post baseline post enrollment confirmation ] The Clinician-Administered PTSD Scale for DSM-V (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
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Original Primary Outcome Measures ICMJE |
Change from Baseline in Clinician-Administered PTSD for DSM 5 [ Time Frame: 18 weeks post baseline post enrollment confirmation ] Global severity Scores on the CAPS-5, a measure of PTSD symptoms
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Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
Change From Baseline to Primary Endpoint in Adapted Sheehan Disability Scale (SDS) Total Score [ Time Frame: Baseline to 18 weeks post enrollment confirmation ] The Sheehan Disability Scale (SDS) is a clinician-rated assessment of functional impairment that was adapted for the purposes of this study to limit missing item-level data as per the FDA requirements and included use of the three-item mean as the total score and imputation of work-related impairment. The SDS is a 3-item scale measuring the severity of disability in the domains of work, family life/home responsibilities and social/leisure activities, with each item scored on a ten-point Likert scale from 0 ('not at all impaired') to 10 ('very severely impaired'). The SDS total score was the mean of the 3 item responses. The SDS total score ranged from 0 to 10, with higher scores indicating greater functional impairment.
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Original Secondary Outcome Measures ICMJE |
Change from Baseline in Sheehan Disability Scale (SDS) total score [ Time Frame: 18 weeks post enrollment confirmation ] Sheehan Disability Scale (SDS) total score, a measure of clinician-rated functional impairment.
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2) | ||||||||||||||
Official Title ICMJE | A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Posttraumatic Stress Disorder of Moderate or Greater Severity | ||||||||||||||
Brief Summary | Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder that can develop after a traumatic life experience that severely reduces quality of life. This multi-site, double-blind, placebo-controlled, randomized Phase 3 study will assess the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy compared to psychotherapy with placebo in participants diagnosed with at least moderate PTSD. The study will be conducted in up to N ≈ 100 participants. Participants will be randomized to receive a flexible dose of 80 or 120 mg MDMA or placebo, followed by a supplemental half-dose of 40 or 60 mg MDMA or placebo, unless contraindicated, with manualized psychotherapy in three monthly Experimental Sessions. This ~12-week Treatment Period will be preceded by three Preparatory Sessions with the participant and therapists. During the Treatment Period, each Experimental Session will be followed by three Integrative Sessions of non-drug psychotherapy. | ||||||||||||||
Detailed Description | Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder that can develop after a person experiences a traumatic event, such as sexual assault, war, or any other life-threatening event. PTSD is a worldwide health problem that severely reduces a person's quality of life and is associated with high rates of psychiatric and medical comorbidity, disability, suffering, and suicide. At least a third of PTSD patients fail to respond to established PTSD psychotherapies. A wider array of effective treatments for PTSD are needed. 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy may be a potential treatment option for PTSD. MDMA is a monoamine releaser that affects serotonin, norepinephrine, and dopamine. MDMA is capable of inducing unique psychopharmacological effects such as decreased feelings of fear, increased feelings of wellbeing, increased sociability and extroversion, increased interpersonal trust, and an alert state of consciousness. In the U.S., MDMA was used as an adjunct to psychotherapy by a considerable number of psychiatrists and therapists before it was placed in Schedule I in 1985 as a result of non-medical use. This multi-site, double-blind, placebo-controlled, randomized Phase 3 study will assess the efficacy and safety of MDMA-assisted psychotherapy versus psychotherapy with placebo control in participants diagnosed with at least moderate PTSD. The study will be conducted in N ≈ 100 participants. Participants will be randomized into one of two groups (MDMA or placebo) in a 1:1 ratio. A flexible dose of MDMA or placebo, followed by a supplemental half-dose unless contraindicated, will be administered during the Treatment Period with manualized psychotherapy in three monthly Experimental Sessions. This ~12-week Treatment Period will be preceded by three Preparatory Sessions with the participant and therapists. Initial doses in each Experimental Session will be 80 mg or 120 mg of MDMA compounded with mannitol and magnesium stearate or placebo alone (mannitol and magnesium stearate), followed 1.5 to 2 hours later by a supplemental half-dose (40 or 60 mg, respectively). Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg. Each Experimental Session will be followed by three Integrative Sessions of non-drug psychotherapy to help the participants process and understand their experiences during the Experimental Sessions. The primary objective of this study is to evaluate the efficacy of MDMA-assisted psychotherapy for PTSD compared to identical psychotherapy with inactive placebo, as measured by change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score from Visit 3 (Baseline) to Visit 19 (18 weeks post Baseline) (Blake et al., 1995). The key secondary objective of this study is to evaluate the efficacy of MDMA-assisted psychotherapy for PTSD compared to identical psychotherapy with inactive placebo in clinician-rated functional impairment, as measured by the change in Sheehan Disability Scale (adapted SDS) item scores from Visit 3 (Baseline) to Visit 19 (18 weeks post Baseline) (Leon et al., 1997). |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized, double-blind between group comparison of change in PTSD symptoms Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Use of separate databases for outcome measures and safety data. Assessment made by pool of independent raters. Randomization will be managed via an Interactive Web Randomization System (IWRS) based on a centralized randomization schedule developed by an independent thirdparty vendor to maintain blinding. Primary Purpose: Treatment
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Condition ICMJE | Posttraumatic Stress Disorder | ||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||
Actual Enrollment ICMJE |
121 | ||||||||||||||
Original Estimated Enrollment ICMJE |
100 | ||||||||||||||
Actual Study Completion Date ICMJE | November 2, 2022 | ||||||||||||||
Actual Primary Completion Date | October 30, 2022 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | Israel, United States | ||||||||||||||
Removed Location Countries | Canada | ||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04077437 | ||||||||||||||
Other Study ID Numbers ICMJE | MAPP2 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Lykos Therapeutics | ||||||||||||||
Original Responsible Party | Multidisciplinary Association for Psychedelic Studies | ||||||||||||||
Current Study Sponsor ICMJE | Lykos Therapeutics | ||||||||||||||
Original Study Sponsor ICMJE | Multidisciplinary Association for Psychedelic Studies | ||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||
Investigators ICMJE |
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PRS Account | Lykos Therapeutics | ||||||||||||||
Verification Date | January 2024 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |