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The goal of this clinical trial is to learn if MDMA in combination with therapy is safe and effective in people with chronic, treatment-resistant PTSD.
The main questions it aims to answer are:
Researchers will compare two active doses (100 mg and 125 mg) of MDMA-assisted therapy versus a comparator dose of 40 mg MDMA-assisted therapy to determine if there is a reduction in PTSD symptoms.
Participants will undergo three non-drug preparatory sessions, three MDMA-assisted therapy sessions and three non-drug integrative therapy sessions after each MDMA-assisted therapy session.
This Phase 2 pilot study is a randomized, double-blind, dose response study to examine the safety and efficacy of MDMA-assisted psychotherapy in 23 subjects with chronic, treatment-resistant PTSD of at least six months duration. This study assessed two active doses of MDMA, active dose 1 (100 mg) and active dose 2 (125 mg), to a comparator dose of MDMA (40 mg) during psychotherapy sessions. The initial dose of MDMA was followed 1.5 to 2.5 hours later by an optional supplemental dose of MDMA that was half the size of the first dose. MDMA was administered orally in two experimental sessions lasting up to eight hours and scheduled three to five weeks apart.
Subjects were prepared for MDMA-assisted psychotherapy in three preparatory sessions prior to the first experimental session, and worked with the same pair of therapists throughout the study. After each experimental session, three integrative sessions were scheduled with the subject, including one integrative session the morning after the experimental session. During integrative sessions, subjects processed and connected their thoughts and feelings about the experience with their therapist team.
Subjects who received the comparator dose (40 mg) were given the option to enroll in Stage 2, where they underwent three open-label MDMA-assisted psychotherapy sessions. 100 mg of MDMA was administered in the first session and therapists determined whether to increase to 125 mg of MDMA for the second and third experimental sessions. People who received 125 mg of MDMA during the first two experimental sessions received the same dose during an open-label third experimental session. People who received 100 mg of MDMA during the first two sessions were able to choose, in consultation with their therapist, to either continue to receive 100 mg in a third session or to increase their dose to 125 mg.
A blinded independent rater (IR) assessed the severity of PTSD symptoms at baseline, one month after the second experimental session (the primary endpoint), two months after the third open-label experimental session, and at equivalent points in Stage 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comparator Dose (40 mg) MDMA-assisted therapy | Active Comparator | Participants receive an initial dose of comparator dose midomafetamine HCl (40 mg) during each of two therapy sessions. |
|
| Active Dose 2 (100 mg) MDMA-assisted therapy | Experimental | Participants receive an initial dose of Active Dose 2 midomafetamine HCl (100 mg) during each of two therapy sessions. |
|
| Active Dose 1 (125 mg) MDMA-assisted therapy | Experimental | Participants receive an initial dose of Active Dose 1 midomafetamine HCl (125 mg) during each of two therapy sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator Dose (40mg) MDMA HCl | Drug | An initial comparator-dose of 40 mg midomafetamine HCl orally given at the start of two separate psychotherapy sessions scheduled 3 to 5 weeks apart, with the initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose half the size of the initial dose (20 mg). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) Total Severity Score From Baseline to One Month Post 2nd Experimental Session | The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. It contains symptom subscales, a CAPS-IV total severity score, and a diagnostic score. 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. | Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PTSD Diagnostic Scale (PDS) From Baseline to One Month Post 2nd Experimental Session | The PTSD Diagnostic Scale (PSD) is self-report measure designed to follow DSM-IV criteria for assessing PTSD. It contains 49 items, with responses made on a four-point scale, ranging from 0 ("not at all") to 3 ("five or more times a week"). The PDS consists of a list of 12 potential traumatic events, 12 items addressing elements of the traumatic event, 17 symptom items, and 9 items assessing impact on areas of life function. Items addressing elements of the traumatic event and life function are answered as either present or not present (Yes or No). The 17 items are summed to create a symptom severity score, with higher scores indicating a greater number and/or intensity of PTSD symptoms. The symptom severity score ranges from 0 to 51. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcela d'Otalora, MA, LPC | Private Practice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Offices of Marcela d'Otalora | Boulder | Colorado | 80304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7712061 | Background | Blake DD, Weathers FW, Nagy LM, Kaloupek DG, Gusman FD, Charney DS, Keane TM. The development of a Clinician-Administered PTSD Scale. J Trauma Stress. 1995 Jan;8(1):75-90. doi: 10.1007/BF02105408. | |
| 6511949 | Background | Beck AT, Steer RA. Internal consistencies of the original and revised Beck Depression Inventory. J Clin Psychol. 1984 Nov;40(6):1365-7. doi: 10.1002/1097-4679(198411)40:63.0.co;2-d. |
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Candidates were recruited via Internet advertisements and referrals from mental health professionals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Comparator Dose MDMA (40 mg) and Psychotherapy | Participants receive an initial dose of 40 mg of MDMA orally, with an optional supplemental dose of 20 mg MDMA 1.5 to 2.5 hours later. |
| FG001 | Active Dose 2 MDMA (100 mg) and Psychotherapy | Participants receive an initial dose of 100 mg of MDMA orally, with an optional supplemental dose of 50 mg MDMA 1.5 to 2.5 hours later. |
| FG002 | Active Dose 1 MDMA (125 mg) and Psychotherapy | Participants receive an initial dose of 125 mg of MDMA orally, with an optional supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 Randomized, Double-blind Period |
| |||||||||||||
| Stage 2 Open-Label Crossover Period |
|
Intent-to-Treat (ITT)
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Dose 1 MDMA (125 mg) and Psychotherapy | Participants receive an initial dose of 125 mg of MDMA orally, with an optional supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later. |
| BG001 | Active Dose 2 MDMA (100 mg) and Psychotherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) Total Severity Score From Baseline to One Month Post 2nd Experimental Session | The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. It contains symptom subscales, a CAPS-IV total severity score, and a diagnostic score. 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. | Modified Intent-to-Treat set (mITT), Stage 1 participants | Posted | Mean | Standard Deviation | score on a scale | Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint) |
|
All AEs from baseline to long-term follow-up (approximately 18 months)
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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 | Active Dose 1 MDMA (125 mg) and Psychotherapy (Stage 1) | Participants receive an initial dose of 125 mg of midomafetamine HCl orally, with an optional supplemental dose of 62.5 mg 1.5 to 2.5 hours later during two blinded sessions. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ruptured ovarian cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Lykos Therapeutics | 877-627-7722 | trialdata@lykospbc.com |
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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 | Aug 15, 2014 | Aug 12, 2021 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 26, 2016 | Jun 19, 2020 | SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 18, 2016 | Jun 14, 2022 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D018817 | N-Methyl-3,4-methylenedioxyamphetamine |
| D011613 | Psychotherapy |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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|
|
| Active Dose 2 (100 mg) MDMA HCl | Drug | An initial dose of full-dose 100 mg midomafetamine HCl orally given at the start of two separate psychotherapy sessions scheduled 3 to 5 weeks apart, with the initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose half the size of the initial dose (50 mg). |
|
|
| Active Dose 1 (125 mg) MDMA HCl | Drug | An initial dose of full-dose 125 mg midomafetamine HCl orally given at the start of two separate psychotherapy sessions scheduled 3 to 5 weeks apart, with the initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose half the size of the initial dose (62.5 mg). |
|
|
| Psychotherapy | Behavioral | Non-directive manualized therapy |
|
|
| Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint) |
| Change in Beck Depression Inventory II (BDI-II) From Baseline to One Month Post 2nd Experimental Session | Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms. | Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint) |
| Change in Global Assessment of Functioning (GAF) Total Score From Baseline to One Month Post 2nd Experimental Session | The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning. | Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint) |
| Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to One Month Post 2nd Experimental Session | The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality. | Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint) |
| Change in Dissociative Experiences Scale (DES-II) From Baseline to One Month Post 2nd Experimental Session | The DES-II is a 28-item self-report measure of dissociation, defined as a lack of normal integration of an individual's thoughts, feelings, or experiences into the stream of consciousness or memory. The scale consists of statements describing facets of dissociation. Respondents indicate how often the specific experience happens to them, from "never" to "always." The DES-II uses the same items but with responses made on a 10 point scale from "0%" to "100%" of the time. The scale is scored by treating percentages as single digits to produce a total score with higher scores indicating greater severity. The total score ranges from 0 to 100. | Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint) |
| Change in Posttraumatic Growth Inventory (PTGI) From Baseline to One Month Post 2nd Experimental Session | The PTGI is a 21-item self-report measure of perceived growth or benefits occurring after a traumatic event. It contains five subscales: relationship to others, new possibilities, personal strength, spiritual change, and appreciation of life. PTGI scores on a 6 point scale are: 0 - I did not experience this as a result of my crisis; 1 - I experienced this change to a very small degree as a result of my crisis; 2 - I experienced this change to a small degree as a result of my crisis; 3 - I experienced this change to a moderate degree as a result of my crisis; 4 - I experienced this change to a great degree as a result of my crisis; and 5 - I experienced this change to a very great degree as a result of my crisis. A total score is calculated by summing the responses to all 21 items, each rated on a 6-point scale, with higher scores indicating greater post-traumatic growth | Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint) |
| 8991972 | Background | Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13. |
| 32500209 | Derived | 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. |
|
| NOT COMPLETED |
|
Participants receive an initial dose of 100 mg of MDMA orally, with an optional supplemental dose of 50 mg MDMA 1.5 to 2.5 hours later. |
| BG002 | Comparator-dose MDMA (40 mg) and Psychotherapy | Participants receive an initial dose of 40 mg of MDMA orally, with an optional supplemental dose of 20 mg MDMA 1.5 to 2.5 hours later. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Participants receive an initial dose of 125 mg of MDMA orally, with an optional supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
| OG001 | Active Dose 2 (100 mg) MDMA and Psychotherapy | Participants receive an initial dose of 100 mg of MDMA orally, with an optional supplemental dose of 50 mg MDMA 1.5 to 2.5 hours later. |
| OG002 | Comparator-dose (40 mg) MDMA and Psychotherapy | Participants receive an initial dose of 40 mg of MDMA orally, with an optional supplemental dose of 20 mg MDMA 1.5 to 2.5 hours later. |
|
|
| Secondary | Change in PTSD Diagnostic Scale (PDS) From Baseline to One Month Post 2nd Experimental Session | The PTSD Diagnostic Scale (PSD) is self-report measure designed to follow DSM-IV criteria for assessing PTSD. It contains 49 items, with responses made on a four-point scale, ranging from 0 ("not at all") to 3 ("five or more times a week"). The PDS consists of a list of 12 potential traumatic events, 12 items addressing elements of the traumatic event, 17 symptom items, and 9 items assessing impact on areas of life function. Items addressing elements of the traumatic event and life function are answered as either present or not present (Yes or No). The 17 items are summed to create a symptom severity score, with higher scores indicating a greater number and/or intensity of PTSD symptoms. The symptom severity score ranges from 0 to 51. | Modified Intent-to-Treat set (mITT), Stage 1 participants | Posted | Mean | Standard Deviation | score on a scale | Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint) |
|
|
|
| Secondary | Change in Beck Depression Inventory II (BDI-II) From Baseline to One Month Post 2nd Experimental Session | Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms. | Modified Intent-to-Treat set (mITT), Stage 1 participants | Posted | Mean | Standard Deviation | score on a scale | Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint) |
|
|
|
| Secondary | Change in Global Assessment of Functioning (GAF) Total Score From Baseline to One Month Post 2nd Experimental Session | The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning. | Modified Intent-to-Treat set (mITT), Stage 1 participants | Posted | Mean | Standard Deviation | score on a scale | Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint) |
|
|
|
| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to One Month Post 2nd Experimental Session | The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality. | Modified Intent-to-Treat set (mITT), Stage 1 participants | Posted | Mean | Standard Deviation | score on a scale | Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint) |
|
|
|
| Secondary | Change in Dissociative Experiences Scale (DES-II) From Baseline to One Month Post 2nd Experimental Session | The DES-II is a 28-item self-report measure of dissociation, defined as a lack of normal integration of an individual's thoughts, feelings, or experiences into the stream of consciousness or memory. The scale consists of statements describing facets of dissociation. Respondents indicate how often the specific experience happens to them, from "never" to "always." The DES-II uses the same items but with responses made on a 10 point scale from "0%" to "100%" of the time. The scale is scored by treating percentages as single digits to produce a total score with higher scores indicating greater severity. The total score ranges from 0 to 100. | Modified Intent-to-Treat set (mITT), Stage 1 participants | Posted | Mean | Standard Deviation | score on a scale | Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint) |
|
|
|
| Secondary | Change in Posttraumatic Growth Inventory (PTGI) From Baseline to One Month Post 2nd Experimental Session | The PTGI is a 21-item self-report measure of perceived growth or benefits occurring after a traumatic event. It contains five subscales: relationship to others, new possibilities, personal strength, spiritual change, and appreciation of life. PTGI scores on a 6 point scale are: 0 - I did not experience this as a result of my crisis; 1 - I experienced this change to a very small degree as a result of my crisis; 2 - I experienced this change to a small degree as a result of my crisis; 3 - I experienced this change to a moderate degree as a result of my crisis; 4 - I experienced this change to a great degree as a result of my crisis; and 5 - I experienced this change to a very great degree as a result of my crisis. A total score is calculated by summing the responses to all 21 items, each rated on a 6-point scale, with higher scores indicating greater post-traumatic growth | Modified Intent-to-Treat set (mITT), Stage 1 participants. 1 Comparator Dose participant did not complete a baseline PTGI assessment so is excluded from this analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint) |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 8 |
| 13 |
| EG001 | Active Dose 2 MDMA (100 mg) and Psychotherapy (Stage 1) | Participants receive an initial dose of 100 mg of midomafetamine HCl orally, with an optional supplemental dose of 50 mg 1.5 to 2.5 hours later during two blinded sessions. | 0 | 9 | 1 | 9 | 6 | 9 |
| EG002 | Comparator-dose MDMA (40 mg) and Psychotherapy (Stage 1) | Participants receive an initial dose of 40 mg of midomafetamine HCl orally, with an optional supplemental dose of 20 mg 1.5 to 2.5 hours later during two blinded sessions. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG003 | Open-Label Session: Active Dose 1 | Participants will receive one open-label MDMA-assisted therapy session with an initial dose of 125 mg of midomafetamine HCl orally, with an optional supplemental dose of 62.5 mg 1.5 to 2.5 hours later. | 0 | 12 | 0 | 12 | 5 | 12 |
| EG004 | Open-Label Session: Active Dose 2 | Participants will receive one open-label MDMA-assisted therapy session with an initial dose of 100 mg of midomafetamine HCl orally, with an optional supplemental dose of 62.5 mg 1.5 to 2.5 hours later. | 0 | 9 | 1 | 9 | 3 | 9 |
| EG005 | Crossover Open-Label Sessions: Comparator Dose | Participants who received the comparator dose during Stage 1 will have the opportunity to crossover and take part in a second study segment, referred to as Stage 2, with three open-label MDMA-assisted therapy sessions. In the first session, the dose will be 100 mg followed 1.5 to 2.5 hours later by an optional supplement dose of 50 mg. In the second and third sessions, participants will have the option to keep the same dose or titrate up to 125 mg, followed 1.5 to 2.5 hours later by 62.5 mg. | 0 | 5 | 0 | 5 | 3 | 5 |
| EG006 | 12 Month Follow-up: Active Dose 1 | Adverse events collected 12 months after the participant's final MDMA-assisted therapy session. | 0 | 11 | 0 | 11 | 2 | 11 |
| EG007 | 12 Month Follow-up: Active Dose 2 | Adverse events collected 12 months after the participant's final MDMA-assisted therapy session. | 0 | 9 | 1 | 9 | 1 | 9 |
| EG008 | 12 Month Follow-up: Comparator Dose | Adverse events collected 12 months after the participant's final MDMA-assisted therapy session (following crossover to receive 3 additional treatment sessions with active dose). | 0 | 5 | 0 | 5 | 1 | 5 |
| EG009 | SRRs: Active Dose 1 | Spontaneously reported reactions (SRRs) on open-label experimental sessions days and 7 days after. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG010 | SRRs: Active Dose 2 | Spontaneously reported reactions (SRRs) on open-label experimental sessions days and 7 days after. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG011 | SRRs: Comparator | Spontaneously reported reactions (SRRs) on open-label experimental sessions days and 7 days after. | 0 | 6 | 0 | 6 | 5 | 6 |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Nausea | Metabolism and nutrition disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Incorrect dose administered | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Skeletal injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Migraine | Nervous system disorders | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | Systematic Assessment |
|
| Irritability | Psychiatric disorders | Systematic Assessment |
|
| Obsessive rumination | Psychiatric disorders | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Feeling abnormal | General disorders | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
|
| Vision blurred | Eye disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Post concussion syndrome | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | Systematic Assessment |
|
| Difficulty Concentrating | General disorders | Systematic Assessment |
|
| Drowsiness | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Impaired Judgment | General disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Jaw Clenching, Tight Jaw | General disorders | Systematic Assessment |
|
| Lack of Appetite | General disorders | Systematic Assessment |
|
| Low mood | General disorders | Systematic Assessment |
|
| Muscle tension | General disorders | Systematic Assessment |
|
| Need more sleep | General disorders | Systematic Assessment |
|
| Perspiration | General disorders | Systematic Assessment |
|
| Ruminations | General disorders | Systematic Assessment |
|
Not provided
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| D001519 | Behavior |
| Organic Chemicals |
| D004191 | Behavioral Disciplines and Activities |