Trial Outcomes & Findings for Randomized Placebo-controlled Study of MDMA-assisted Therapy in People With PTSD - Israel (NCT NCT00402298)
NCT ID: NCT00402298
Last Updated: 2025-06-05
Results Overview
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.
TERMINATED
PHASE2
5 participants
Baseline to two months after second MDMA-assisted experimental session
2025-06-05
Participant Flow
Participant milestones
| Measure |
Full Dose (125 mg)
Participants will receive an initial dose of 125 mg MDMNA followed 2.5 hours later by a supplemental dose of 62.5 mg MDMA during the course of two day-long psychotherapy sessions.
3,4-methylenedioxymethemphetmaine (MDMA\_: Participants will receive an initial dose of 125 mg MDMA orally followed 2.5 hours later by 62.5 mg MDMA orally during the course of a day-long psychotherapy session.
|
Low Dose (25 mg)
25 and 12.5 mg MDMA
3,4-methylenedioxymethamphetamine: Participants will receive an initial dose of 25 mg MDMA orally followed 2.5 hours alter by a supplemental dose of 12.5 mg MDMA orally during the course of each of two day-long psychotherapy sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Full Dose (125 mg)
Participants will receive an initial dose of 125 mg MDMNA followed 2.5 hours later by a supplemental dose of 62.5 mg MDMA during the course of two day-long psychotherapy sessions.
3,4-methylenedioxymethemphetmaine (MDMA\_: Participants will receive an initial dose of 125 mg MDMA orally followed 2.5 hours later by 62.5 mg MDMA orally during the course of a day-long psychotherapy session.
|
Low Dose (25 mg)
25 and 12.5 mg MDMA
3,4-methylenedioxymethamphetamine: Participants will receive an initial dose of 25 mg MDMA orally followed 2.5 hours alter by a supplemental dose of 12.5 mg MDMA orally during the course of each of two day-long psychotherapy sessions.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Randomized Placebo-controlled Study of MDMA-assisted Therapy in People With PTSD - Israel
Baseline characteristics by cohort
| Measure |
Full Dose (125 mg)
n=3 Participants
Participants will receive an initial dose of 125 mg MDMNA followed 2.5 hours later by a supplemental dose of 62.5 mg MDMA during the course of two day-long psychotherapy sessions.
3,4-methylenedioxymethemphetmaine (MDMA\_: Participants will receive an initial dose of 125 mg MDMA orally followed 2.5 hours later by 62.5 mg MDMA orally during the course of a day-long psychotherapy session.
|
Active Comparator (25 mg)
n=2 Participants
25 and 12.5 mg MDMA
3,4-methylenedioxymethamphetamine: Participants will receive an initial dose of 25 mg MDMA orally followed 2.5 hours alter by a supplemental dose of 12.5 mg MDMA orally during the course of each of two day-long psychotherapy sessions.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
45.6 Years
n=5 Participants
|
39 Years
n=7 Participants
|
43 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to two months after second MDMA-assisted experimental sessionPopulation: One Full Dose participant did not complete a CAPS-IV assessment at the 2-month endpoint and is accordingly not included in this analysis.
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.
Outcome measures
| Measure |
Full Dose (125 mg) MDMA-assisted Therapy
n=2 Participants
Participants will receive an initial dose of 125 mg midomafetamine HCl followed 2.5 hours later by a supplemental dose of 62.5 mg midomafetamine HCl during the course of two day-long psychotherapy sessions.
|
Low Dose (25 mg) MDMA-assisted Therapy
n=2 Participants
Participants will receive an initial dose of 25 mg midomafetamine HCl orally followed 2.5 hours alter by a supplemental dose of 12.5 mg midomafetamine HCl orally during the course of each of two day-long psychotherapy sessions.
|
|---|---|---|
|
Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 2-Month Follow-Up
|
-0.5 units on a scale
Standard Deviation 4.95
|
-7 units on a scale
Standard Deviation 18.38
|
SECONDARY outcome
Timeframe: Baseline to six months after second MDMA-assisted experimental sessionPopulation: One Full Dose participant and one Low Dose participant did not complete a 6-month CAPS-IV assessment and are accordingly not included in this analysis.
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.
Outcome measures
| Measure |
Full Dose (125 mg) MDMA-assisted Therapy
n=2 Participants
Participants will receive an initial dose of 125 mg midomafetamine HCl followed 2.5 hours later by a supplemental dose of 62.5 mg midomafetamine HCl during the course of two day-long psychotherapy sessions.
|
Low Dose (25 mg) MDMA-assisted Therapy
n=1 Participants
Participants will receive an initial dose of 25 mg midomafetamine HCl orally followed 2.5 hours alter by a supplemental dose of 12.5 mg midomafetamine HCl orally during the course of each of two day-long psychotherapy sessions.
|
|---|---|---|
|
Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 6-Month Follow-Up
|
-0.5 score on a scale
Standard Deviation 6.36
|
6 score on a scale
|
SECONDARY outcome
Timeframe: Baseline to twelve months after second MDMA-assisted experimental sessionPopulation: This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection. Limited data were reported to the sponsor and its quality could not be assured. All available data are reported; 12 month follow-up data available in 2 Full Dose participants, no 12 month follow-up data available in Low Dose participants.
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.
Outcome measures
| Measure |
Full Dose (125 mg) MDMA-assisted Therapy
n=2 Participants
Participants will receive an initial dose of 125 mg midomafetamine HCl followed 2.5 hours later by a supplemental dose of 62.5 mg midomafetamine HCl during the course of two day-long psychotherapy sessions.
|
Low Dose (25 mg) MDMA-assisted Therapy
Participants will receive an initial dose of 25 mg midomafetamine HCl orally followed 2.5 hours alter by a supplemental dose of 12.5 mg midomafetamine HCl orally during the course of each of two day-long psychotherapy sessions.
|
|---|---|---|
|
Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 12-month Follow-up
|
-7.5 score on a scale
Standard Deviation 13.43
|
—
|
Adverse Events
Full Dose (125 mg) MDMA-assisted Therapy
Low Dose (25 mg) MDMA-assisted Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Full Dose (125 mg) MDMA-assisted Therapy
n=3 participants at risk
Participants will receive an initial dose of 125 mg MDMNA followed 2.5 hours later by a supplemental dose of 62.5 mg MDMA during the course of two day-long psychotherapy sessions.
3,4-methylenedioxymethemphetmaine (MDMA\_: Participants will receive an initial dose of 125 mg MDMA orally followed 2.5 hours later by 62.5 mg MDMA orally during the course of a day-long psychotherapy session.
|
Low Dose (25 mg) MDMA-assisted Therapy
n=2 participants at risk
25 and 12.5 mg MDMA
3,4-methylenedioxymethamphetamine: Participants will receive an initial dose of 25 mg MDMA orally followed 2.5 hours alter by a supplemental dose of 12.5 mg MDMA orally during the course of each of two day-long psychotherapy sessions.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fasciculation
|
33.3%
1/3 • From informed consent to study termination after 12 month follow up
This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection. Limited data were reported to the sponsor and its quality could not be assured and therefore not analyzed.
|
50.0%
1/2 • From informed consent to study termination after 12 month follow up
This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection. Limited data were reported to the sponsor and its quality could not be assured and therefore not analyzed.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • From informed consent to study termination after 12 month follow up
This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection. Limited data were reported to the sponsor and its quality could not be assured and therefore not analyzed.
|
0.00%
0/2 • From informed consent to study termination after 12 month follow up
This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection. Limited data were reported to the sponsor and its quality could not be assured and therefore not analyzed.
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3 • From informed consent to study termination after 12 month follow up
This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection. Limited data were reported to the sponsor and its quality could not be assured and therefore not analyzed.
|
0.00%
0/2 • From informed consent to study termination after 12 month follow up
This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection. Limited data were reported to the sponsor and its quality could not be assured and therefore not analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Viral upper respiratory tract infection
|
0.00%
0/3 • From informed consent to study termination after 12 month follow up
This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection. Limited data were reported to the sponsor and its quality could not be assured and therefore not analyzed.
|
50.0%
1/2 • From informed consent to study termination after 12 month follow up
This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection. Limited data were reported to the sponsor and its quality could not be assured and therefore not analyzed.
|
|
Musculoskeletal and connective tissue disorders
Myoclonus
|
0.00%
0/3 • From informed consent to study termination after 12 month follow up
This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection. Limited data were reported to the sponsor and its quality could not be assured and therefore not analyzed.
|
50.0%
1/2 • From informed consent to study termination after 12 month follow up
This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection. Limited data were reported to the sponsor and its quality could not be assured and therefore not analyzed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place