Trial Outcomes & Findings for Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD (NCT NCT03282123)
NCT ID: NCT03282123
Last Updated: 2025-06-05
Results Overview
The Clinician-Administered PTSD Scale for DSM-V (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Baseline to 18 weeks post-enrollment
Results posted on
2025-06-05
Participant Flow
Subjects were recruited through print and internet advertisements, referrals from other psychiatrists, psychotherapists, or physicians, and by word of mouth. The sponsor monitored demographics on an ongoing basis and encouraged diversity in enrollment by communicating with sites
Participant milestones
| Measure |
MDMA-assisted Psychotherapy
Three sessions of MDMA-assisted psychotherapy with flexible dose of MDMA from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
MDMA: 80 to 120 mg MDMA
Psychotherapy: Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
MDMA-assisted Psychotherapy
Three sessions of MDMA-assisted psychotherapy with flexible dose of MDMA from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
MDMA: 80 to 120 mg MDMA
Psychotherapy: Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD
Baseline characteristics by cohort
| Measure |
MDMA-assisted Psychotherapy
n=33 Participants
Three sessions of MDMA-assisted psychotherapy with flexible dose of MDMA from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
MDMA: 80 to 120 mg MDMA
Psychotherapy: Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session
|
|---|---|
|
Age, Continuous
|
36.42 years
STANDARD_DEVIATION 11.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Baseline CAPS-5 Total Severity Score
|
45.4 score on a scale
STANDARD_DEVIATION 6.70 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 18 weeks post-enrollmentPopulation: Safety Set
The Clinician-Administered PTSD Scale for DSM-V (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Outcome measures
| Measure |
MDMA-assisted Therapy
n=33 Participants
Three sessions of MDMA-assisted therapy with flexible dose of MDMA from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
MDMA: 80 to 120 mg MDMA
Psychotherapy: Non-directive therapy conducted during MDMA-assisted therapy session
|
|---|---|
|
Change From Baseline to Visit 19 in CAPS-5 Total Severity Scores
|
-30.49 score on a scale
Interval -34.16 to -26.83
|
SECONDARY outcome
Timeframe: Baseline to 18 weeks post-enrollmentPopulation: Safety Set
The Sheehan Disability Scale (SDS) is a clinician-rated assessment of functional impairment that was adapted for the purposes of this study to limit missing item-level data as per the FDA requirements and included use of the three-item mean as the total score and imputation of work-related impairment. The SDS is a 3-item scale measuring the severity of disability in the domains of work, family life/home responsibilities and social/leisure activities, with each item scored on a ten-point Likert scale from 0 ('not at all impaired') to 10 ('very severely impaired'). The SDS total score was the mean of the 3 item responses. The SDS total score ranged from 0 to 10, with higher scores indicating greater functional impairment.
Outcome measures
| Measure |
MDMA-assisted Therapy
n=33 Participants
Three sessions of MDMA-assisted therapy with flexible dose of MDMA from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
MDMA: 80 to 120 mg MDMA
Psychotherapy: Non-directive therapy conducted during MDMA-assisted therapy session
|
|---|---|
|
Change From Baseline to Visit 19 in Adapted SDS Total Score
|
-4.88 score on a scale
Interval -5.7 to -4.06
|
Adverse Events
MDMA-assisted Psychotherapy
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MDMA-assisted Psychotherapy
n=33 participants at risk
Three sessions of MDMA-assisted psychotherapy with flexible dose of MDMA from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
MDMA: 80 to 120 mg MDMA
Psychotherapy: Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session
|
|---|---|
|
Psychiatric disorders
Suicide attempt
|
3.0%
1/33 • Number of events 1 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
Other adverse events
| Measure |
MDMA-assisted Psychotherapy
n=33 participants at risk
Three sessions of MDMA-assisted psychotherapy with flexible dose of MDMA from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
MDMA: 80 to 120 mg MDMA
Psychotherapy: Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session
|
|---|---|
|
Cardiac disorders
Palpitations
|
9.1%
3/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Eye disorders
Vision Blurred
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
12.1%
4/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Gastrointestinal disorders
Nausea
|
33.3%
11/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Gastrointestinal disorders
Dry Mouth
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
General disorders
Fatigue
|
24.2%
8/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
General disorders
Temperature Intolerance
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
General disorders
Chest Discomfort
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
General disorders
Pain
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
12.1%
4/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
12.1%
4/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
3/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
54.5%
18/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
9.1%
3/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Nervous system disorders
Nystagmus
|
24.2%
8/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Nervous system disorders
Headache
|
66.7%
22/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Nervous system disorders
Dizziness
|
15.2%
5/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Nervous system disorders
Paraesthesia
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Psychiatric disorders
Anxiety
|
27.3%
9/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Psychiatric disorders
Insomnia
|
33.3%
11/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Psychiatric disorders
Restlessness
|
9.1%
3/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Psychiatric disorders
Panic Reaction
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Psychiatric disorders
Flashback
|
9.1%
3/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Psychiatric disorders
Bruxism
|
9.1%
3/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Psychiatric disorders
Suicidal Ideation
|
27.3%
9/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.1%
4/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
3/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Nervous system disorders
Dysgeusia
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
General disorders
Chills
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
General disorders
Pyrexia
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Infections and infestations
Nasopharyngitis
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Nervous system disorders
Taste disorder
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Renal and urinary disorders
Micturition urgency
|
6.1%
2/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
|
Eye disorders
Visual impairment
|
9.1%
3/33 • All treatment-emergent adverse events until end of study (approximately 5 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60