Trial Outcomes & Findings for Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With PTSD (NCT NCT01958593)
NCT ID: NCT01958593
Last Updated: 2025-06-05
Results Overview
Clinician-administered and scored assessment of PTSD symptoms via structured interview, including global symptom severity, dichotomous diagnostic score and subscale scores. The Clinician-Administered PTSD Scale for DSM-4 (CAPS-4) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-4. It contains symptom subscales, a CAPS-4 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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Baseline to Primary Endpoint (Primary Endpoint was approximately 18 weeks after Baseline and 1 month after the 2nd experimental session)
Results posted on
2025-06-05
Participant Flow
Participants were recruited through printed ads, internet ads, referrals from other psychiatrists, psychotherapists or physicians, and through word of mouth.
Participant milestones
| Measure |
Placebo With Therapy
Participants will receive placebo with therapy during each of two experimental sessions.
|
MDMA-assisted Therapy
Participants will receive full-dose (125 mg) MDMA with therapy during each of two experimental sessions.
|
|---|---|---|
|
Stage 1
STARTED
|
2
|
4
|
|
Stage 1
COMPLETED
|
2
|
4
|
|
Stage 1
NOT COMPLETED
|
0
|
0
|
|
Stage 2 Open-label Crossover
STARTED
|
2
|
0
|
|
Stage 2 Open-label Crossover
COMPLETED
|
2
|
0
|
|
Stage 2 Open-label Crossover
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With PTSD
Baseline characteristics by cohort
| Measure |
Placebo With Therapy
n=2 Participants
Participants will receive placebo with therapy during each of two blinded experimental sessions.
|
MDMA-assisted Therapy
n=4 Participants
Participants will receive MDMA-assisted therapy during each of two blinded experimental sessions.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 12.66 • n=5 Participants
|
49.6 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
47.7 years
STANDARD_DEVIATION 8.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Primary Endpoint (Primary Endpoint was approximately 18 weeks after Baseline and 1 month after the 2nd experimental session)Clinician-administered and scored assessment of PTSD symptoms via structured interview, including global symptom severity, dichotomous diagnostic score and subscale scores. The Clinician-Administered PTSD Scale for DSM-4 (CAPS-4) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-4. It contains symptom subscales, a CAPS-4 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.
Outcome measures
| Measure |
Placebo With Therapy
n=2 Participants
Participants will receive placebo with therapy during each of two experimental sessions.
|
MDMA-assisted Therapy
n=4 Participants
Participants will receive full-dose (125 mg) MDMA with therapy during each of two experimental sessions.
|
|---|---|---|
|
Change in Clinician-Administered PTSD Scale (CAPS-IV) Score From Baseline to Primary Endpoint
|
-21.5 score on a scale
Standard Deviation 12.02
|
-17.3 score on a scale
Standard Deviation 13.05
|
SECONDARY outcome
Timeframe: Baseline to Primary Endpoint (Primary Endpoint was approximately 18 weeks after Baseline and 1 month after the 2nd experimental session)Population: One participant in the MDMA group did not provide PDS data at Primary Endpoint so is excluded from this analysis.
The PTSD Diagnostic Scale (PDS) is a 49 item self-report measure designed to follow DSM-IV criteria for assessing PTSD. The PDS consists of a checklist to identify potentially traumatizing events experienced by the respondent and respondents then indicate which of the experienced events has troubled them the most in the last month and rate their response to this event at the time of its occurrence. Respondents then rate the severity of 17 items representing the cardinal symptoms of PTSD experienced in the past 30 days on a scale from 0 ("not at all") to 3 ("5 or more times a week") as well as the level of impairment caused by their symptoms across nine areas of life functioning. The 17 symptom severity items are summed to create a total symptom severity score, which ranges from 0 to 51, with higher scores indicating greater symptom severity and/or frequency.
Outcome measures
| Measure |
Placebo With Therapy
n=2 Participants
Participants will receive placebo with therapy during each of two experimental sessions.
|
MDMA-assisted Therapy
n=3 Participants
Participants will receive full-dose (125 mg) MDMA with therapy during each of two experimental sessions.
|
|---|---|---|
|
Change in PTSD Diagnostic Scale (PDS) Total Severity Score From Baseline to Primary Endpoint
|
-1.0 score on a scale
Standard Deviation 5.66
|
-5.3 score on a scale
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Baseline to Primary Endpoint (Primary Endpoint was approximately 18 weeks after Baseline and 1 month after the 2nd experimental session)The BDI-II is a validated 21-item self-report measure of symptoms of depression according to DSM-IV criteria. A 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.
Outcome measures
| Measure |
Placebo With Therapy
n=2 Participants
Participants will receive placebo with therapy during each of two experimental sessions.
|
MDMA-assisted Therapy
n=4 Participants
Participants will receive full-dose (125 mg) MDMA with therapy during each of two experimental sessions.
|
|---|---|---|
|
Change in Beck Depression Inventory (BDI-II) Score From Baseline to Primary Endpoint
|
-4.0 score on a scale
Standard Deviation 2.83
|
2.0 score on a scale
Standard Deviation 15.34
|
SECONDARY outcome
Timeframe: Baseline to Primary Endpoint (Primary Endpoint was approximately 18 weeks after Baseline and 1 month after the 2nd experimental session)The GAF Scale is a numeric scale ranging from 0 (serious risk of causing harm to the self or others) through 100 (superior function) that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. The GAF is a reliable, validated measure of social functioning (Goldman, Skodol, and Lave, 1992). Higher scores indicate better functioning.
Outcome measures
| Measure |
Placebo With Therapy
n=2 Participants
Participants will receive placebo with therapy during each of two experimental sessions.
|
MDMA-assisted Therapy
n=4 Participants
Participants will receive full-dose (125 mg) MDMA with therapy during each of two experimental sessions.
|
|---|---|---|
|
Change in Global Assessment of Functioning (GAF) Score From Baseline to Primary Endpoint
|
5.0 score on a scale
Standard Deviation 4.24
|
5.3 score on a scale
Standard Deviation 3.86
|
SECONDARY outcome
Timeframe: Baseline to Primary Endpoint (Primary Endpoint was approximately 18 weeks after Baseline and 1 month after the 2nd experimental session)The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 19 items that yield 7 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.
Outcome measures
| Measure |
Placebo With Therapy
n=2 Participants
Participants will receive placebo with therapy during each of two experimental sessions.
|
MDMA-assisted Therapy
n=4 Participants
Participants will receive full-dose (125 mg) MDMA with therapy during each of two experimental sessions.
|
|---|---|---|
|
Change in Pittsburgh Sleep Quality Index (PSQI) Score From Baseline to Primary Endpoint
|
1.0 score on a scale
Standard Deviation 1.41
|
-3.5 score on a scale
Standard Deviation 3.32
|
SECONDARY outcome
Timeframe: Baseline to Primary Endpoint (Primary Endpoint was approximately 18 weeks after Baseline and 1 month after the 2nd experimental session)Population: DES-II data was not collected in one MDMA participant at the endpoint assessment so is excluded from this analysis.
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. It is an established measure of dissociative symptoms. The scale consists of statements describing facets of dissociation. Respondents indicate how often the specific experience happens to them, from from "never" (0% of the time) to "always" (100%). The scale is scored by treating percentages as single digits and averaging to produce a total score, ranging from 0 to 100. The higher the score, the more dissociative symptoms.
Outcome measures
| Measure |
Placebo With Therapy
n=2 Participants
Participants will receive placebo with therapy during each of two experimental sessions.
|
MDMA-assisted Therapy
n=3 Participants
Participants will receive full-dose (125 mg) MDMA with therapy during each of two experimental sessions.
|
|---|---|---|
|
Change in Dissociation Experiences Scale II (DES-II) Total Score From Baseline to Primary Endpoint
|
8.4 score on a scale
Standard Deviation 3.79
|
-4.6 score on a scale
Standard Deviation 13.63
|
SECONDARY outcome
Timeframe: Baseline to Primary Endpoint (Primary Endpoint was approximately 18 weeks after Baseline and 1 month after the 2nd experimental session)Population: PTGI data was not collected in one MDMA participant at the endpoint assessment so is excluded from this analysis.
The PTGI is a 21-item self-report measure of perceived growth or benefits occurring after a traumatic event. It contains 5 subscales: relationship to others, new possibilities, personal strength, spiritual change, and appreciation of life. Responses to each question are made on a scale of 0 (no change) to 5 (great degree of change), with higher scores indicating greater personal growth. Items are added to calculate the total PTGI score which ranges from 0 to 105, with higher scores indicative of greater growth.
Outcome measures
| Measure |
Placebo With Therapy
n=2 Participants
Participants will receive placebo with therapy during each of two experimental sessions.
|
MDMA-assisted Therapy
n=3 Participants
Participants will receive full-dose (125 mg) MDMA with therapy during each of two experimental sessions.
|
|---|---|---|
|
Change in Posttraumatic Growth Inventory (PTGI) Total Score From Baseline to Primary Endpoint
|
8.5 score on a scale
Standard Deviation 14.85
|
-3.7 score on a scale
Standard Deviation 11.85
|
Adverse Events
Placebo With Therapy (Stage 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MDMA-assisted Therapy (Stage 1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo With Therapy (Stage 2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SRRs: Placebo With Therapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SRRs: MDMA-assisted Therapy
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo With Therapy (Stage 1)
n=2 participants at risk
Participants will receive placebo during each of two experimental sessions.
Placebo: Placebo administered in two experimental sessions; may take part in Stage 2 upon learning condition assignment
Psychotherapy: Psychotherapy before and after experimental sessions
|
MDMA-assisted Therapy (Stage 1)
n=4 participants at risk
Participants will receive full-dose MDMA during each of two experimental sessions.
3,4-methylenedioxymethamphetamine: Participants receive full-dose MDMA during two experimental sessions; after learning their condition assignment, participants will receive a third full-dose session.
Psychotherapy: Psychotherapy before and after experimental sessions
|
Placebo With Therapy (Stage 2)
n=2 participants at risk
Stage 1 placebo participants will receive full-dose MDMA during each of two experimental sessions.
3,4-methylenedioxymethamphetamine: Participants receive full-dose MDMA during two experimental sessions; after learning their condition assignment, participants will receive a third full-dose session.
Psychotherapy: Psychotherapy before and after experimental sessions
|
SRRs: Placebo With Therapy
n=2 participants at risk
Spontaneously reported reactions (SRRs) on blinded experimental session days and 7 days after.
|
SRRs: MDMA-assisted Therapy
n=4 participants at risk
Spontaneously reported reactions (SRRs) on blinded experimental session days and 7 days after.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
25.0%
1/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
100.0%
2/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
100.0%
4/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
25.0%
1/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
25.0%
1/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
50.0%
2/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
100.0%
2/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
100.0%
4/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
25.0%
1/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
50.0%
1/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
75.0%
3/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
General disorders
Fatigue
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
25.0%
1/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
100.0%
2/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
100.0%
4/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
General disorders
Pain
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
25.0%
1/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
25.0%
1/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
50.0%
2/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
Psychiatric disorders
Emotional distress
|
50.0%
1/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
25.0%
1/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
25.0%
1/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
Psychiatric disorders
Dissociation
|
50.0%
1/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
25.0%
1/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
100.0%
2/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
100.0%
4/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
Psychiatric disorders
Intentional self-injury
|
50.0%
1/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
50.0%
1/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
25.0%
1/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
25.0%
1/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
50.0%
1/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
25.0%
1/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
General disorders
Diarrhea
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
50.0%
2/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
General disorders
Difficulty Concentrating
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
100.0%
2/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
75.0%
3/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
General disorders
Dizziness
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
25.0%
1/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
General disorders
Dry mouth
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
25.0%
1/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
General disorders
Impaired Gait/Balance
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
50.0%
2/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
General disorders
Increased Irritability
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
50.0%
1/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
25.0%
1/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
General disorders
Jaw Clenching, Tight Jaw
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
50.0%
2/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
General disorders
Lack of Appetite
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
50.0%
2/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
General disorders
Low mood
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
100.0%
2/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
75.0%
3/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
General disorders
Muscle Tension
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
100.0%
2/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
75.0%
3/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
General disorders
Need More Sleep
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
100.0%
2/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
75.0%
3/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
General disorders
Perspiration
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
50.0%
1/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
50.0%
2/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
General disorders
Ruminations
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
50.0%
1/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
75.0%
3/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
General disorders
Sensitivity to Cold
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
50.0%
2/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
|
General disorders
Weakness
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
0.00%
0/2 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
25.0%
1/4 • All AEs from baseline to the end of Stage 2 (approximately 10 months)
Treatment group is the Stage 1 randomized treatment assignment (i.e. Results for "Placebo with Therapy" participants in Stage 2 reflect results following open-label crossover to complete 3 MDMA-assisted therapy sessions).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place