Trial Outcomes & Findings for Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD (Canada) (NCT NCT03485287)
NCT ID: NCT03485287
Last Updated: 2025-06-10
Results Overview
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 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.
COMPLETED
PHASE2
4 participants
Baseline (Visit 3) to Primary Endpoint (Visit 19,18 weeks post enrollment)
2025-06-10
Participant Flow
Participants will be recruited through print and internet advertisements, referrals from other psychiatrists, psychotherapists, or physicians, and by word of mouth.
Participant milestones
| Measure |
MDMA-assisted Therapy (100 to 125 mg)
Three sessions of open-label MDMA-assisted therapy with flexible dose of midomafetamine HCl from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD (Canada)
Baseline characteristics by cohort
| Measure |
MDMA-assisted Therapy (100 to 125 mg)
n=4 Participants
Three sessions of open-label MDMA-assisted therapy with flexible dose of midomafetamine HCl from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
|
|---|---|
|
Age, Continuous
|
29.25 years
STANDARD_DEVIATION 5.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Disabled from Work
Yes
|
1 Participants
n=5 Participants
|
|
Disabled from Work
No
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Visit 3) to Primary Endpoint (Visit 19,18 weeks post enrollment)Population: Safety Set
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 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 |
MDMA-assisted Therapy (100 to 125 mg of MDMA)
n=4 Participants
Three sessions of open-label MDMA-assisted therapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later.
|
|---|---|
|
Change From Baseline to Primary Endpoint in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
|
-25.00 score on a scale
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: Baseline (Visit 3) to Primary Endpoint (Visit 19, 18 weeks post-enrollment)Population: Safety Set
The Sheehan Disability Scale (SDS for PTSD for MAPS) is a self-report assessment of functional impairment. The reporting period for the adapted SDS refers to the past month. The items indicate degree of impairment in the domains of work/school, social life, and home life, with response options based on an eleven-point scale (0=not at all to 10=extremely), with higher scores indicating greater functional impairment.
Outcome measures
| Measure |
MDMA-assisted Therapy (100 to 125 mg of MDMA)
n=4 Participants
Three sessions of open-label MDMA-assisted therapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later.
|
|---|---|
|
Change From Baseline to Primary Endpoint in Sheehan Disability Scale (SDS for PTSD for MAPS) Total Score
SDS Total Score at Baseline
|
7.4 score on a scale
Standard Deviation 1.6
|
|
Change From Baseline to Primary Endpoint in Sheehan Disability Scale (SDS for PTSD for MAPS) Total Score
SDS Total Score at Primary Endpoint
|
2.3 score on a scale
Standard Deviation 2.98
|
Adverse Events
MDMA-assisted Therapy (100 to 125 mg)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MDMA-assisted Therapy (100 to 125 mg)
n=4 participants at risk
Three sessions of open-label MDMA-assisted therapy with flexible dose of midomafetamine HCl from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later.
|
|---|---|
|
Cardiac disorders
Palpitations
|
50.0%
2/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Gastrointestinal disorders
Aphthous ulcer
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
General disorders
Fatigue
|
50.0%
2/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
General disorders
Feeling cold
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
General disorders
Viral upper respiratory tract infection
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Injury, poisoning and procedural complications
Fracture
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Injury, poisoning and procedural complications
Laceration
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Nervous system disorders
Dizziness
|
50.0%
2/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Nervous system disorders
Headache
|
75.0%
3/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Nervous system disorders
Paraesthesia
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Nervous system disorders
Sensory disturbance
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Nervous system disorders
Syncope
|
50.0%
2/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Psychiatric disorders
Aggression
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Psychiatric disorders
Anxiety
|
75.0%
3/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Nervous system disorders
Depressed mood
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Psychiatric disorders
Depression
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Psychiatric disorders
Derealisation
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Psychiatric disorders
Insomnia
|
50.0%
2/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Psychiatric disorders
Nightmare
|
50.0%
2/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Psychiatric disorders
Suicidal ideation
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
|
Vascular disorders
Peripheral coldness
|
25.0%
1/4 • Treatment-emergent adverse events through study completion (approximately 5 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place