Trial Outcomes & Findings for Randomized, Double-blind, Placebo-Controlled Pilot Study of MDMA-assisted Therapy for PTSD (NCT NCT01689740)
NCT ID: NCT01689740
Last Updated: 2025-06-06
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. 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
10 participants
Primary outcome timeframe
Baseline to 1-Month Post Experimental Session 2 (End of Stage 1)
Results posted on
2025-06-06
Participant Flow
Participants were recruited through printed ads, internet ads, referrals from other psychiatrists, psychotherapists or physicians, through the Israeli Defense Forces (IDF) and through word of mouth.
Participant milestones
| Measure |
Open-Label: 125 mg MDMA-assisted Therapy
Open label: Participants receive initial dose of 125 mg midomafetamine HCl possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
|
Blinded: Full Dose MDMA-assisted Therapy
Participants receive initial dose of 125 mg midomafetamine HCl possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
Blinded: Active Placebo Dose MDMA-assisted Therapy
Participants receive initial doses of 25 mg midomafetamine HCl possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
|---|---|---|---|
|
Stage 1
STARTED
|
2
|
5
|
3
|
|
Stage 1
COMPLETED
|
2
|
5
|
3
|
|
Stage 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Stage 2
STARTED
|
0
|
0
|
2
|
|
Stage 2
COMPLETED
|
0
|
0
|
2
|
|
Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
|
12 Month Follow-Up
STARTED
|
2
|
5
|
3
|
|
12 Month Follow-Up
COMPLETED
|
2
|
5
|
2
|
|
12 Month Follow-Up
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized, Double-blind, Placebo-Controlled Pilot Study of MDMA-assisted Therapy for PTSD
Baseline characteristics by cohort
| Measure |
Lead in: 125 mg MDMA (Open Label) and Psychotherapy
n=2 Participants
Participants receive open MDMA with an initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
|
Full Dose MDMA (125 mg) and Psychotherapy
n=5 Participants
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
Active Placebo Dose MDMA (25 mg) and Psychotherapy
n=3 Participants
Participants receive initial doses of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 19.72 • n=99 Participants
|
35.1 years
STANDARD_DEVIATION 10.21 • n=107 Participants
|
38.5 years
STANDARD_DEVIATION 8.68 • n=206 Participants
|
37.2 years
STANDARD_DEVIATION 10.57 • n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White/Caucasian
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to 1-Month Post Experimental Session 2 (End of Stage 1)Population: Intent-to-Treat (ITT)
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. 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 |
Lead in: 125 mg MDMA (Open Label) and Psychotherapy
n=2 Participants
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
|
Active Placebo Dose MDMA (25 mg) and Psychotherapy
n=3 Participants
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
Full Dose MDMA (125 mg) and Psychotherapy
n=5 Participants
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
|---|---|---|---|
|
Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to End of Stage 1
|
-42.0 score on a scale
Standard Deviation 9.90
|
-9.0 score on a scale
Standard Deviation 15.62
|
-34.6 score on a scale
Standard Deviation 16.29
|
SECONDARY outcome
Timeframe: Baseline to End of Stage 2The 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. 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 |
Lead in: 125 mg MDMA (Open Label) and Psychotherapy
n=2 Participants
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
|
Active Placebo Dose MDMA (25 mg) and Psychotherapy
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
Full Dose MDMA (125 mg) and Psychotherapy
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
|---|---|---|---|
|
Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to End of Stage 2
|
-23.0 score on a scale
Standard Deviation 15.56
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 months post-final experimental sessionPopulation: Intent-to-Treat set (ITT)
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. 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 |
Lead in: 125 mg MDMA (Open Label) and Psychotherapy
n=2 Participants
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
|
Active Placebo Dose MDMA (25 mg) and Psychotherapy
n=2 Participants
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
Full Dose MDMA (125 mg) and Psychotherapy
n=5 Participants
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
|---|---|---|---|
|
Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to Long-Term Follow-Up
|
-39.0 score on a scale
Standard Deviation 14.14
|
-34.5 score on a scale
Standard Deviation 20.51
|
-48.8 score on a scale
Standard Deviation 20.39
|
SECONDARY outcome
Timeframe: Baseline to 1-Month Post Experimental Session 2 (End of Stage 1)Population: Intent-to-Treat set (ITT)
Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.
Outcome measures
| Measure |
Lead in: 125 mg MDMA (Open Label) and Psychotherapy
n=2 Participants
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
|
Active Placebo Dose MDMA (25 mg) and Psychotherapy
n=3 Participants
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
Full Dose MDMA (125 mg) and Psychotherapy
n=5 Participants
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
|---|---|---|---|
|
Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to End of Stage 1
|
-17.0 score on a scale
Standard Deviation 2.83
|
0.3 score on a scale
Standard Deviation 4.73
|
-17.0 score on a scale
Standard Deviation 12.59
|
SECONDARY outcome
Timeframe: Baseline to End of Stage 2Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.
Outcome measures
| Measure |
Lead in: 125 mg MDMA (Open Label) and Psychotherapy
n=2 Participants
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
|
Active Placebo Dose MDMA (25 mg) and Psychotherapy
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
Full Dose MDMA (125 mg) and Psychotherapy
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
|---|---|---|---|
|
Change in Beck Depression Inventory (BDI-II) Total Score From Baseline to End of Stage 2
|
-6.5 score on a scale
Standard Deviation 4.95
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 month post-final experimental sessionPopulation: Intent-to-Treat set (ITT)
Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63.
Outcome measures
| Measure |
Lead in: 125 mg MDMA (Open Label) and Psychotherapy
n=2 Participants
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
|
Active Placebo Dose MDMA (25 mg) and Psychotherapy
n=2 Participants
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
Full Dose MDMA (125 mg) and Psychotherapy
n=5 Participants
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
|---|---|---|---|
|
Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to Long-Term Follow-Up
|
-17.0 score on a scale
Standard Deviation 5.66
|
-3.5 score on a scale
Standard Deviation 4.95
|
-18.4 score on a scale
Standard Deviation 11.10
|
SECONDARY outcome
Timeframe: Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1)Population: Intent-to-Treat set (ITT)
The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.
Outcome measures
| Measure |
Lead in: 125 mg MDMA (Open Label) and Psychotherapy
n=2 Participants
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
|
Active Placebo Dose MDMA (25 mg) and Psychotherapy
n=3 Participants
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
Full Dose MDMA (125 mg) and Psychotherapy
n=5 Participants
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
|---|---|---|---|
|
Change in Global Assessment of Functioning (GAF) Scale From Baseline to End of Stage 1
|
15.0 score on a scale
Standard Deviation 21.21
|
-2.3 score on a scale
Standard Deviation 8.74
|
18.2 score on a scale
Standard Deviation 11.14
|
SECONDARY outcome
Timeframe: Baseline to End of Stage 2The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.
Outcome measures
| Measure |
Lead in: 125 mg MDMA (Open Label) and Psychotherapy
n=2 Participants
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
|
Active Placebo Dose MDMA (25 mg) and Psychotherapy
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
Full Dose MDMA (125 mg) and Psychotherapy
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
|---|---|---|---|
|
Change in Global Assessment of Functioning (GAF) Scale From Baseline to End of Stage 2
|
8.0 score on a scale
Standard Deviation 9.90
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 months post-final experimental sessionPopulation: Intent-to-Treat set (ITT)
The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.
Outcome measures
| Measure |
Lead in: 125 mg MDMA (Open Label) and Psychotherapy
n=2 Participants
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
|
Active Placebo Dose MDMA (25 mg) and Psychotherapy
n=2 Participants
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
Full Dose MDMA (125 mg) and Psychotherapy
n=5 Participants
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
|---|---|---|---|
|
Change in Global Assessment of Functioning (GAF) Scale From Baseline to Long-Term Follow-Up
|
5 score on a scale
Standard Deviation 7.07
|
-1.5 score on a scale
Standard Deviation 0.71
|
26.6 score on a scale
Standard Deviation 10.33
|
SECONDARY outcome
Timeframe: Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1)Population: Intent-to-Treat set (ITT)
The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms.
Outcome measures
| Measure |
Lead in: 125 mg MDMA (Open Label) and Psychotherapy
n=2 Participants
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
|
Active Placebo Dose MDMA (25 mg) and Psychotherapy
n=3 Participants
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
Full Dose MDMA (125 mg) and Psychotherapy
n=5 Participants
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
|---|---|---|---|
|
Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to End of Stage 1
|
-19.0 score on a scale
Standard Deviation 5.66
|
1.3 score on a scale
Standard Deviation 13.43
|
-17.4 score on a scale
Standard Deviation 9.91
|
SECONDARY outcome
Timeframe: Baseline to End of Stage 2The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms.
Outcome measures
| Measure |
Lead in: 125 mg MDMA (Open Label) and Psychotherapy
n=2 Participants
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
|
Active Placebo Dose MDMA (25 mg) and Psychotherapy
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
Full Dose MDMA (125 mg) and Psychotherapy
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
|---|---|---|---|
|
Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to End of Stage 2
|
-11.5 score on a scale
Standard Deviation 10.61
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 months post-final experimental sessionPopulation: Intent-to-Treat set (ITT)
The Posttraumatic Stress Diagnostic Scale (PDS) is a 49-item self-report instrument designed to aid in the diagnosis of PTSD. Responses to 17 symptom items are made on a 4 point scale ranging from 0 (not at all) to 3 (five or more times per week). The symptom items are summed to calculate the symptom severity score which ranges from 0 to 51, with higher scores indicating more severe PTSD symptoms.
Outcome measures
| Measure |
Lead in: 125 mg MDMA (Open Label) and Psychotherapy
n=2 Participants
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
|
Active Placebo Dose MDMA (25 mg) and Psychotherapy
n=2 Participants
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
Full Dose MDMA (125 mg) and Psychotherapy
n=5 Participants
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
|---|---|---|---|
|
Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to Long-Term Follow-Up
|
-23.0 score on a scale
Standard Deviation 0
|
-10 score on a scale
Standard Deviation 9.90
|
-20.4 score on a scale
Standard Deviation 12.70
|
SECONDARY outcome
Timeframe: Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1)Population: Intent-to-Treat set (ITT)
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.
Outcome measures
| Measure |
Lead in: 125 mg MDMA (Open Label) and Psychotherapy
n=2 Participants
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
|
Active Placebo Dose MDMA (25 mg) and Psychotherapy
n=3 Participants
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
Full Dose MDMA (125 mg) and Psychotherapy
n=5 Participants
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
|---|---|---|---|
|
Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to End of Stage 1
|
-7.5 score on a scale
Standard Deviation 6.36
|
1.0 score on a scale
Standard Deviation 5.29
|
-1.8 score on a scale
Standard Deviation 4.44
|
SECONDARY outcome
Timeframe: Baseline to End of Stage 2Population: Crossover set
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.
Outcome measures
| Measure |
Lead in: 125 mg MDMA (Open Label) and Psychotherapy
n=2 Participants
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
|
Active Placebo Dose MDMA (25 mg) and Psychotherapy
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
Full Dose MDMA (125 mg) and Psychotherapy
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
|---|---|---|---|
|
Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to End of Stage 2
|
-3.5 score on a scale
Standard Deviation 3.54
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 months post-final experimental sessionPopulation: Intent-to-Treat set (ITT)
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.
Outcome measures
| Measure |
Lead in: 125 mg MDMA (Open Label) and Psychotherapy
n=2 Participants
Open label: Participants receive open-label MDMA with initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions.
|
Active Placebo Dose MDMA (25 mg) and Psychotherapy
n=2 Participants
Participants receive initial dose of 25 mg MDMA possibly followed by a supplemental dose of 12.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
Full Dose MDMA (125 mg) and Psychotherapy
n=5 Participants
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart.
|
|---|---|---|---|
|
Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to Long-Term Follow-Up
|
-3.5 score on a scale
Standard Deviation 3.54
|
-2.0 score on a scale
Standard Deviation 4.24
|
-2.2 score on a scale
Standard Deviation 5.40
|
Adverse Events
Lead In Open-Label: 125 mg MDMA-assisted Therapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Blinded Full Dose MDMA-assisted Therapy (125 mg) (Stage 1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Blinded Active Placebo MDMA-assisted Therapy (Stage 1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Open-Label Full Dose MDMA-assisted Therapy (125 mg) (Stage 2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
12 Month Follow-Up: Open-Label Full Dose Lead-In
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
12 Month Follow-Up: Blinded Full Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
12 Month Follow-Up: Active Placebo Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SRRs: Full Dose
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
SRRs: Active Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lead In Open-Label: 125 mg MDMA-assisted Therapy
n=2 participants at risk
Participants receive initial dose of 125 mg midomafetamine HCl possibly followed by a supplemental dose of 62.5 mg during two therapy sessions.
|
Blinded Full Dose MDMA-assisted Therapy (125 mg) (Stage 1)
n=5 participants at risk
Participants receive initial dose of 125 mg midomafetamine HCl possibly followed by a supplemental dose of 62.5 mg during two therapy sessions scheduled 3-5 weeks apart.
|
Blinded Active Placebo MDMA-assisted Therapy (Stage 1)
n=3 participants at risk
Participants receive initial dose of 25 mg midomafetamine HCl possibly followed by a supplemental dose of 12.5 mg during two therapy sessions scheduled 3-5 weeks apart.
|
Open-Label Full Dose MDMA-assisted Therapy (125 mg) (Stage 2)
n=2 participants at risk
Stage 1 activate placebo dose participants receive initial dose of 125 mg midomafetamine HCl possibly followed by a supplemental dose of 62.5 mg during two therapy sessions scheduled 3-5 weeks apart.
|
12 Month Follow-Up: Open-Label Full Dose Lead-In
n=2 participants at risk
Includes Adverse Events that start on or after the day after end of Stage 1 for subject who did not cross over to Stage 2 or end of Stage 2 through the end of the study.
|
12 Month Follow-Up: Blinded Full Dose
n=5 participants at risk
Includes Adverse Events that start on or after the day after end of Stage 1 for subject who did not cross over to Stage 2 or end of Stage 2 through the end of the study.
|
12 Month Follow-Up: Active Placebo Dose
n=3 participants at risk；n=2 participants at risk
Includes Adverse Events that start on or after the day after end of Stage 1 for subject who did not cross over to Stage 2 or end of Stage 2 through the end of the study.
|
SRRs: Full Dose
n=5 participants at risk
Spontaneously reported reactions (SRRs) during blinded experimental sessions and 7 days after.
|
SRRs: Active Placebo
n=3 participants at risk
Spontaneously reported reactions (SRRs) during blinded experimental sessions and 7 days after.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
20.0%
1/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
40.0%
2/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
20.0%
1/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
General disorders
Pyrexia
|
50.0%
1/2 • From baseline to study completion (approximately 18 months)
|
20.0%
1/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
20.0%
1/5 • From baseline to study completion (approximately 18 months)
|
33.3%
1/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
20.0%
1/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
80.0%
4/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
40.0%
2/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
40.0%
2/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
Psychiatric disorders
Anxiety
|
50.0%
1/2 • From baseline to study completion (approximately 18 months)
|
80.0%
4/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
100.0%
5/5 • From baseline to study completion (approximately 18 months)
|
33.3%
1/3 • From baseline to study completion (approximately 18 months)
|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
100.0%
5/5 • From baseline to study completion (approximately 18 months)
|
33.3%
1/3 • From baseline to study completion (approximately 18 months)
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
20.0%
1/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
20.0%
1/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
50.0%
1/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
50.0%
1/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
50.0%
1/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
Musculoskeletal and connective tissue disorders
Tremor
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
50.0%
1/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
Psychiatric disorders
Posttraumatic stress disorder
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
50.0%
1/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
Social circumstances
Exposure to violent event
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
50.0%
1/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
Psychiatric disorders
Anger
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
50.0%
1/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
50.0%
1/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
Psychiatric disorders
Major depression
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
20.0%
1/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
General disorders
Drowsiness
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
20.0%
1/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
General disorders
Fatigue
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
100.0%
5/5 • From baseline to study completion (approximately 18 months)
|
66.7%
2/3 • From baseline to study completion (approximately 18 months)
|
|
General disorders
Heavy legs
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
20.0%
1/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
General disorders
Increased irritability
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
40.0%
2/5 • From baseline to study completion (approximately 18 months)
|
33.3%
1/3 • From baseline to study completion (approximately 18 months)
|
|
General disorders
Jaw Clenching, Tight Jaw
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
40.0%
2/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
General disorders
Lack of Appetite
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
20.0%
1/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
General disorders
Low mood
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
60.0%
3/5 • From baseline to study completion (approximately 18 months)
|
66.7%
2/3 • From baseline to study completion (approximately 18 months)
|
|
General disorders
Muscle tension
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
40.0%
2/5 • From baseline to study completion (approximately 18 months)
|
66.7%
2/3 • From baseline to study completion (approximately 18 months)
|
|
General disorders
Need more sleep
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
60.0%
3/5 • From baseline to study completion (approximately 18 months)
|
33.3%
1/3 • From baseline to study completion (approximately 18 months)
|
|
General disorders
Perspiration
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
20.0%
1/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
General disorders
Restlessness
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
60.0%
3/5 • From baseline to study completion (approximately 18 months)
|
66.7%
2/3 • From baseline to study completion (approximately 18 months)
|
|
General disorders
Thirst
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
20.0%
1/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
|
General disorders
Weakness
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/2 • From baseline to study completion (approximately 18 months)
|
0.00%
0/5 • From baseline to study completion (approximately 18 months)
|
0.00%
0/3 • From baseline to study completion (approximately 18 months)
|
40.0%
2/5 • From baseline to study completion (approximately 18 months)
|
33.3%
1/3 • From baseline to study completion (approximately 18 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60