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| Name | Class |
|---|---|
| Swiss Medical Society for Psycholytic Therapy | OTHER |
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This study will examine MDMA-assisted psychotherapy in individuals aged 18 years or older diagnosed with PTSD, with PTSD symptoms not improving after trying at least one treatment. This objective of this study is to determine whether three eight-hour long sessions of MDMA-assisted psychotherapy, scheduled three to five weeks apart, can be safely administered to participants with PTSD, and whether combining a fully therapeutic dose of MDMA with psychotherapy, when compared with a low ("active placebo") dose of MDMA, will reduce PTSD symptoms. Participants will be randomly assigned to receive the full dose of MDMA (125 mg) or assigned to receive a low or "active placebo" dose of MDMA (25 mg) during each of three experimental sessions.
Posttraumatic stress disorder (PTSD) occurs after experiencing a traumatic event or events. PTSD is a public health problem that causes a great deal of suffering.
This study will examine MDMA-assisted psychotherapy in individuals aged 18 years or older diagnosed with PTSD, with PTSD symptoms not improving after trying at least one treatment. This objective of this study is to determine whether three eight-hour long sessions of MDMA-assisted psychotherapy, scheduled three to five weeks apart, can be safely administered to participants with PTSD, and whether combining a fully therapeutic dose of MDMA with psychotherapy, when compared with a low ("active placebo") dose of MDMA, will reduce PTSD symptoms. Participants will be randomly assigned to receive the full dose of MDMA (125 mg) or assigned to receive a low or "active placebo" dose of MDMA (25 mg) during each of three experimental sessions.
People who receive the low dose of MDMA have the opportunity to take part in a second "open label" study continuation, wherein the participants will undergo three MDMA-assisted sessions, with the participant and the researchers knowing that a full dose of MDMA is being administered. People who receive the full dose of MDMA, and any person who received low-dose MDMA and does not undergo the open-label study continuation will have PTSD symptoms measured six and twelve months after the third session. People who take part in the open label study continuation have their PTSD symptoms assessed six and 12 months after the third Phase II MDMA-assisted session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full Dose MDMA-assisted therapy (125 mg) | Experimental | Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA |
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| Active Placebo MDMA-assisted therapy (25 mg) | Active Comparator | Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3,4-methylenedioxymethamphetamine (125 mg) | Drug | Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Primary Endpoint in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) | The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. | Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Primary Endpoint in Posttraumatic Stress Diagnostic Scale (PDS) | The Posstraumatic Stress Diagnostic Scale (PSD) is a 49-item self-report instrument to aid in the diagnosis of PTSD. Questions are asked about symptoms experienced and participants respond on a scale from 0 ("not at all or only one time") to 3 ("5 or more times a week/almost always"). Items are summed to create a total score that ranges from 0 to 51, with higher scores indicating more PTSD symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Oehen, MD | private practice, Biberist, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Offices of Peter Oehen MD | Biberist | Canton of Solothurn | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23118021 | Result | Oehen P, Traber R, Widmer V, Schnyder U. A randomized, controlled pilot study of MDMA (+/- 3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD). J Psychopharmacol. 2013 Jan;27(1):40-52. doi: 10.1177/0269881112464827. Epub 2012 Oct 31. | |
| 32500209 | Derived |
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Only active control participants from Stage 1 entered into open-label Stage 2 and only participants who received full dose in Stage1 or Stage 2 and did not respond with significant improvement were offered the opportunity to partake in open-label Stage 3.
Participants were recruited by calling for referrals from psychiatric hospitals, trauma counseling centers, psychiatrists and psychotherapists in the German-speaking part of Switzerland.
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| ID | Title | Description |
|---|---|---|
| FG000 | Full Dose MDMA-assisted Therapy (125 mg Stage 1) | Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA 3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapists |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 20, 2010 | Feb 26, 2024 |
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| 3,4-methyelendioxymethamphetamine (25 mg) | Drug | Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally. |
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| Therapy | Behavioral | Non-directive therapy performed by a team of two co-therapists |
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| Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint) |
| Jerome L, Feduccia AA, Wang JB, Hamilton S, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials. Psychopharmacology (Berl). 2020 Aug;237(8):2485-2497. doi: 10.1007/s00213-020-05548-2. Epub 2020 Jun 4. |
| 31572236 | Derived | Feduccia AA, Jerome L, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline. Front Psychiatry. 2019 Sep 12;10:650. doi: 10.3389/fpsyt.2019.00650. eCollection 2019. |
| 31065731 | Derived | Mithoefer MC, Feduccia AA, Jerome L, Mithoefer A, Wagner M, Walsh Z, Hamilton S, Yazar-Klosinski B, Emerson A, Doblin R. 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. Psychopharmacology (Berl). 2019 Sep;236(9):2735-2745. doi: 10.1007/s00213-019-05249-5. Epub 2019 May 7. |
| FG001 | Active Placebo MDMA-assisted Therapy (25 mg Stage 1) | Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA 3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapists |
| FG002 | Full Dose MDMA-assisted Therapy (125 mg Stage 2) | Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA 3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally. |
| FG003 | Full or Larger Dose MDMA-assisted Therapy (125 or 150 mg Stage 3) | Two 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA, or a 20% larger dose of 150 mg MDMA, followed by a supplemental dose of 75 mg administered 2.5 hours later. 3,4-methylenedioxymethamphetamine (125 or 150 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally or Participants will receive an initial dose of 150 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 75 mg MDMA orally. |
| Completed Stage 2 |
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| Completed Stage 3 |
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| COMPLETED | Completed Stage 1 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Full Dose MDMA-assisted Therapy (125 mg) | Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA 3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapists |
| BG001 | Active Placebo MDMA-assisted Therapy (25 mg) | Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA 3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapists |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Country of origin | Count of Participants | Participants |
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| Work status | Count of Participants | Participants |
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| Duration of PTSD | Mean | Standard Deviation | years |
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| Duration of prior therapy | Mean | Standard Deviation | months |
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| On medication for PTSD at enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Primary Endpoint in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) | The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. | Posted | Mean | Standard Deviation | score on a scale | Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint) |
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| Secondary | Change From Baseline to Primary Endpoint in Posttraumatic Stress Diagnostic Scale (PDS) | The Posstraumatic Stress Diagnostic Scale (PSD) is a 49-item self-report instrument to aid in the diagnosis of PTSD. Questions are asked about symptoms experienced and participants respond on a scale from 0 ("not at all or only one time") to 3 ("5 or more times a week/almost always"). Items are summed to create a total score that ranges from 0 to 51, with higher scores indicating more PTSD symptoms. | Posted | Mean | Standard Deviation | score on a scale | Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint) |
|
From baseline to end of Stage 3 (approximately 1 year)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Full Dose MDMA-assisted Therapy (125 mg Stage 1) | Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA 3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapists | 0 | 9 | 2 | 9 | 8 | 9 |
| EG001 | Active Placebo MDMA-assisted Therapy (25 mg Stage 1) | Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA 3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapists | 0 | 5 | 0 | 5 | 3 | 5 |
| EG002 | Full Dose MDMA-assisted Therapy (125 mg Stage 2) | Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA 3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally. | 0 | 4 | 0 | 4 | 2 | 4 |
| EG003 | Full or Larger Dose MDMA-assisted Therapy (125 or 150 mg Stage 3) | Two 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA, or a 20% larger dose of 150 mg MDMA, followed by a supplemental dose of 75 mg administered 2.5 hours later. 3,4-methylenedioxymethamphetamine (125 or 150 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally or Participants will receive an initial dose of 150 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 75 mg MDMA orally. | 0 | 3 | 0 | 3 | 1 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Metasteses to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Suicidal behavior | Psychiatric disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Panic attack | Psychiatric disorders | Non-systematic Assessment |
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| Red blood cell sedimentation rate increased | Investigations | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Depressed mood | Psychiatric disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Disturbance in attention | Psychiatric disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Hypothyroidism | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | Non-systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pneumonia chlamydial | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Somatoform disorder | Psychiatric disorders | Non-systematic Assessment |
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| Somnolence | Psychiatric disorders | Non-systematic Assessment |
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| Tension | Psychiatric disorders | Non-systematic Assessment |
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| Visual acuity reduced | Nervous system disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Intentional self-injury | Psychiatric disorders | Non-systematic Assessment |
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| Iron deficiency Anemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Otitis media | Ear and labyrinth disorders | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
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| Pain | General disorders | Non-systematic Assessment |
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| Bronchial disorder | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | Non-systematic Assessment |
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| Angina tonsillitus | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie B. Wang, MPH, PhD/ Senior Clinical Data Scientist | Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corp. | (831) 429-6362 | juliewang@mapsbcorp.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 26, 2011 | Feb 26, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 17, 2007 | Jun 14, 2022 | ICF_000.pdf |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018817 | N-Methyl-3,4-methylenedioxyamphetamine |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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