Posttraumatic Stress Disorder (PTSD)
Conditions
Keywords
MDMA, Posttraumatic stress disorder, PTSD, Israel, psychotherapy, midomafetamine
Brief summary
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with chronic, treatment-resistant PTSD. The main question it aims to answer is: Is there a reduction in PTSD symptoms in people given a low dose of MDMA with therapy versus a high dose of MDMA with therapy? Researchers will compare two sessions of MDMA-assisted therapy with either 25 mg of MDMA HCl or 125 mg of MDMA HCl in Stage 1. Participants will undergo preparatory therapy sessions without any study drug, followed by two sessions of MDMA-assisted therapy, each followed by integrative therapy sessions without study drug. Participants who received 25 mg during Stage 1 will be given the option to enroll in Stage 2 and complete two additional open-label MDMA-assisted therapy sessions with the full dose of 125 mg MDMA.
Detailed description
This randomized, double-blind, active placebo-controlled Phase 2 pilot study investigated the safety and efficacy of MDMA-assisted psychotherapy in 10 people with chronic, treatment-resistant posttraumatic stress disorder (PTSD), comparing the effects of low and full dose MDMA as an adjunct to psychotherapy. The first two subjects were enrolled in the open label full dose lead-in with 125 mg of midomafetamine HCl, followed by a supplemental half-dose of 62.5 mg after 1.5 to 2.5 hours. The remaining eight subjects enrolled in Stage 1 of the study and received either an active placebo dose (low dose of 25 mg midomafetamine HCl with a supplemental half-dose of 12.5 mg) or a fully active dose (125 mg midomafetamine HCl with a supplemental half-dose of 62.5 mg) during two experimental psychotherapy session, each lasting six to eight hours and scheduled three to five weeks apart. Upon enrollment, subjects met with their therapist team for three preparatory sessions. After each MDMA-assisted psychotherapy session, subjects met with their therapist team for integrative psychotherapy sessions. The extent of PTSD symptoms was assessed at baseline and two months after the second experimental session using the Clinician Administered PTSD Scale (CAPS) (Blake et al., 1995). Safety measures, vital signs, and a measurement of psychological distress was assessed during all experimental sessions. Blood pressure and heart rate were assessed periodically during each experimental session. Subjects who enrolled in Stage 1 and received the active placebo had the opportunity to enroll in Stage 2 of the study and complete open-label experimental sessions with the fully active dose of midomafetamine HCl (125 mg and 62.5 mg supplemental) on the same schedule as Stage 1.
Interventions
DRUGActive Placebo Dose MDMA-assisted therapy (25 mg)
Initial dose of 25 mg midomafetamine HCl administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 12.5 mg 1.5 to 2.5 hours later.
DRUGFull Dose MDMA-assisted therapy (125 mg)
Initial dose of 125 mg midomafetamine HCl administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 62.5 mg 1.5 to 2.5 hours later.
DRUGOpen-Label Full Dose MDMA-assisted therapy (125 mg)
Initial dose of 125 mg midomafetamine HCl administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 62.5 mg 1.5 to 2.5 hours later.
BEHAVIORALPsychotherapy
Non-directive psychotherapy will be conducted throughout the study.
Sponsors
Lykos Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with chronic PTSD with a duration of 6 months or longer. * Have a CAPS score showing moderate to severe symptoms. * Had at least one unsuccessful attempt at treatment for PTSD, either with talk therapy or with drugs, or stopped treatment because of inability to tolerate psychotherapy or drug therapy. * Are at least 18 years old. * Generally healthy. * Must sign a medical release for the investigators to communicate directly with their therapist and doctors. * Are willing to refrain from taking any psychiatric medications during the study period. * Agree that, one week before the MDMA session, will refrain from taking all below unless with prior approval of research team: herbal supplements, nonprescription medications (with the exception of nonsteroidal anti-inflammatory drugs or acetaminophen, any prescription medications, with the exception of birth control pills, thyroid hormone, or other medications; * Are willing to follow restrictions and guidelines concerning consumption of food, beverages. and nicotine the night before and just prior to each experimental session. * Are willing to remain overnight at the study site. * Are willing to be contacted via telephone for all necessary telephone contacts. * Must have a negative pregnancy test if able to bear children, and agree to use an effective form of birth control. * Agree not to participate in any other clinical trial for the duration of this clinical trial, including the follow-up period. * Are proficient in speaking and reading Hebrew. * Agree to have all psychotherapy sessions recorded to audio/video.
Exclusion criteria
* Are pregnant or nursing, or if they can have children and are not practicing an effective means of birth control. * Weigh less than 48 kg. * Are abusing illegal drugs. * Have used Ecstasy (material represented as containing MDMA) more than five times or at least once within 6 months of the MDMA session. * Are unable to give adequate informed consent. * Upon review of past and current drugs/medication must not be on or have taken a medication that is exclusionary. * Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to End of Stage 1 | Baseline to 1-Month Post Experimental Session 2 (End of Stage 1) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to Long-Term Follow-Up | Baseline to 12 months post-final experimental session | 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. |
| Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to End of Stage 1 | Baseline to 1-Month Post Experimental Session 2 (End of Stage 1) | 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. |
| Change in Beck Depression Inventory (BDI-II) Total Score From Baseline to End of Stage 2 | Baseline to End of Stage 2 | 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. |
| Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to Long-Term Follow-Up | Baseline to 12 month post-final experimental session | 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. |
| Change in Global Assessment of Functioning (GAF) Scale From Baseline to End of Stage 1 | Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1) | 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. |
| Change in Global Assessment of Functioning (GAF) Scale From Baseline to End of Stage 2 | Baseline to End of Stage 2 | 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. |
| Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to End of Stage 2 | Baseline to End of Stage 2 | 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. |
| Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to End of Stage 1 | Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1) | 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. |
| Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to End of Stage 2 | Baseline to End of Stage 2 | 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. |
| Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to Long-Term Follow-Up | Baseline to 12 months post-final experimental session | 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. |
| Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to End of Stage 1 | Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1) | 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. |
| Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to End of Stage 2 | Baseline to End of Stage 2 | 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. |
| Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to Long-Term Follow-Up | Baseline to 12 months post-final experimental session | 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. |
| Change in Global Assessment of Functioning (GAF) Scale From Baseline to Long-Term Follow-Up | Baseline to 12 months post-final experimental session | 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. |
Countries
Israel
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Lead in: 125 mg MDMA (Open Label) and Psychotherapy 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. | 2 |
| 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. | 5 |
| Active Placebo Dose MDMA (25 mg) and Psychotherapy 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. | 3 |
| Total | 10 |
Baseline characteristics
| Characteristic | Lead in: 125 mg MDMA (Open Label) and Psychotherapy | Full Dose MDMA (125 mg) and Psychotherapy | Active Placebo Dose MDMA (25 mg) and Psychotherapy | Total |
|---|---|---|---|---|
| Age, Continuous | 40.5 years STANDARD_DEVIATION 19.72 | 35.1 years STANDARD_DEVIATION 10.21 | 38.5 years STANDARD_DEVIATION 8.68 | 37.2 years STANDARD_DEVIATION 10.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity White/Caucasian | 2 Participants | 5 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 5 | 0 / 3 | 0 / 2 | 0 / 2 | 0 / 5 | 0 / 2 | 0 / 5 | 0 / 3 |
| other Total, other adverse events | 2 / 2 | 4 / 5 | 1 / 3 | 2 / 2 | 0 / 2 | 1 / 5 | 0 / 3 | 5 / 5 | 3 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 5 | 0 / 3 | 0 / 2 | 0 / 2 | 0 / 5 | 0 / 2 | 0 / 5 | 0 / 3 |
Outcome results
Primary
Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to End of Stage 1
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.
Time frame: Baseline to 1-Month Post Experimental Session 2 (End of Stage 1)
Population: Intent-to-Treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lead in: 125 mg MDMA (Open Label) and Psychotherapy | 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 9.9 |
| Active Placebo Dose MDMA (25 mg) and Psychotherapy | Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to End of Stage 1 | -9.0 score on a scale | Standard Deviation 15.62 |
| Full Dose MDMA (125 mg) and Psychotherapy | Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to End of Stage 1 | -34.6 score on a scale | Standard Deviation 16.29 |
Secondary
Change in Beck Depression Inventory (BDI-II) Total Score From Baseline to End of Stage 2
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.
Time frame: Baseline to End of Stage 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lead in: 125 mg MDMA (Open Label) and Psychotherapy | 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
Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to End of Stage 1
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.
Time frame: Baseline to 1-Month Post Experimental Session 2 (End of Stage 1)
Population: Intent-to-Treat set (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lead in: 125 mg MDMA (Open Label) and Psychotherapy | 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 |
| Active Placebo Dose MDMA (25 mg) and Psychotherapy | Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to End of Stage 1 | 0.3 score on a scale | Standard Deviation 4.73 |
| Full Dose MDMA (125 mg) and Psychotherapy | Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to End of Stage 1 | -17.0 score on a scale | Standard Deviation 12.59 |
Secondary
Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to Long-Term Follow-Up
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.
Time frame: Baseline to 12 month post-final experimental session
Population: Intent-to-Treat set (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lead in: 125 mg MDMA (Open Label) and Psychotherapy | 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 |
| Active Placebo Dose MDMA (25 mg) and Psychotherapy | Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to Long-Term Follow-Up | -3.5 score on a scale | Standard Deviation 4.95 |
| Full Dose MDMA (125 mg) and Psychotherapy | Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to Long-Term Follow-Up | -18.4 score on a scale | Standard Deviation 11.1 |
Secondary
Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to End of Stage 2
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.
Time frame: Baseline to End of Stage 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lead in: 125 mg MDMA (Open Label) and Psychotherapy | 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
Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to Long-Term Follow-Up
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.
Time frame: Baseline to 12 months post-final experimental session
Population: Intent-to-Treat set (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lead in: 125 mg MDMA (Open Label) and Psychotherapy | 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 |
| Active Placebo Dose MDMA (25 mg) and Psychotherapy | Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to Long-Term Follow-Up | -34.5 score on a scale | Standard Deviation 20.51 |
| Full Dose MDMA (125 mg) and Psychotherapy | Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to Long-Term Follow-Up | -48.8 score on a scale | Standard Deviation 20.39 |
Secondary
Change in Global Assessment of Functioning (GAF) Scale From Baseline to End of Stage 1
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.
Time frame: Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1)
Population: Intent-to-Treat set (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lead in: 125 mg MDMA (Open Label) and Psychotherapy | 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 |
| Active Placebo Dose MDMA (25 mg) and Psychotherapy | Change in Global Assessment of Functioning (GAF) Scale From Baseline to End of Stage 1 | -2.3 score on a scale | Standard Deviation 8.74 |
| Full Dose MDMA (125 mg) and Psychotherapy | Change in Global Assessment of Functioning (GAF) Scale From Baseline to End of Stage 1 | 18.2 score on a scale | Standard Deviation 11.14 |
Secondary
Change in Global Assessment of Functioning (GAF) Scale From Baseline to End of Stage 2
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.
Time frame: Baseline to End of Stage 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lead in: 125 mg MDMA (Open Label) and Psychotherapy | Change in Global Assessment of Functioning (GAF) Scale From Baseline to End of Stage 2 | 8.0 score on a scale | Standard Deviation 9.9 |
Secondary
Change in Global Assessment of Functioning (GAF) Scale From Baseline to Long-Term Follow-Up
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.
Time frame: Baseline to 12 months post-final experimental session
Population: Intent-to-Treat set (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lead in: 125 mg MDMA (Open Label) and Psychotherapy | Change in Global Assessment of Functioning (GAF) Scale From Baseline to Long-Term Follow-Up | 5 score on a scale | Standard Deviation 7.07 |
| Active Placebo Dose MDMA (25 mg) and Psychotherapy | Change in Global Assessment of Functioning (GAF) Scale From Baseline to Long-Term Follow-Up | -1.5 score on a scale | Standard Deviation 0.71 |
| Full Dose MDMA (125 mg) and Psychotherapy | Change in Global Assessment of Functioning (GAF) Scale From Baseline to Long-Term Follow-Up | 26.6 score on a scale | Standard Deviation 10.33 |
Secondary
Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to End of Stage 1
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.
Time frame: Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1)
Population: Intent-to-Treat set (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lead in: 125 mg MDMA (Open Label) and Psychotherapy | Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to End of Stage 1 | -7.5 score on a scale | Standard Deviation 6.36 |
| Active Placebo Dose MDMA (25 mg) and Psychotherapy | Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to End of Stage 1 | 1.0 score on a scale | Standard Deviation 5.29 |
| Full Dose MDMA (125 mg) and Psychotherapy | Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to End of Stage 1 | -1.8 score on a scale | Standard Deviation 4.44 |
Secondary
Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to End of Stage 2
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.
Time frame: Baseline to End of Stage 2
Population: Crossover set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lead in: 125 mg MDMA (Open Label) and Psychotherapy | 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
Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to Long-Term Follow-Up
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.
Time frame: Baseline to 12 months post-final experimental session
Population: Intent-to-Treat set (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lead in: 125 mg MDMA (Open Label) and Psychotherapy | Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to Long-Term Follow-Up | -3.5 score on a scale | Standard Deviation 3.54 |
| Active Placebo Dose MDMA (25 mg) and Psychotherapy | Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to Long-Term Follow-Up | -2.0 score on a scale | Standard Deviation 4.24 |
| Full Dose MDMA (125 mg) and Psychotherapy | Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to Long-Term Follow-Up | -2.2 score on a scale | Standard Deviation 5.4 |
Secondary
Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to End of Stage 1
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.
Time frame: Baseline to 1-Month Post 2nd Experimental Session (End of Stage 1)
Population: Intent-to-Treat set (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lead in: 125 mg MDMA (Open Label) and Psychotherapy | 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 |
| Active Placebo Dose MDMA (25 mg) and Psychotherapy | Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to End of Stage 1 | 1.3 score on a scale | Standard Deviation 13.43 |
| Full Dose MDMA (125 mg) and Psychotherapy | Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to End of Stage 1 | -17.4 score on a scale | Standard Deviation 9.91 |
Secondary
Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to End of Stage 2
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.
Time frame: Baseline to End of Stage 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lead in: 125 mg MDMA (Open Label) and Psychotherapy | 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
Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to Long-Term Follow-Up
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.
Time frame: Baseline to 12 months post-final experimental session
Population: Intent-to-Treat set (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lead in: 125 mg MDMA (Open Label) and Psychotherapy | 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 |
| Active Placebo Dose MDMA (25 mg) and Psychotherapy | Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to Long-Term Follow-Up | -10 score on a scale | Standard Deviation 9.9 |
| Full Dose MDMA (125 mg) and Psychotherapy | Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to Long-Term Follow-Up | -20.4 score on a scale | Standard Deviation 12.7 |