Posttraumatic Stress Disorder
Conditions
Keywords
PTSD, therapy, MDMA, dyad, cognitive behavioral therapy
Brief summary
The goal of this clinical trial is to learn if cognitive-behavioral conjoint therapy (CBCT) in combination with MDMA-assisted therapy is safe and effective in people with chronic PTSD and their partners. The main question it aims to answer is: Does MDMA-assisted CBCT reduce PTSD symptoms in people with chronic PTSD? Participants (chronic PTSD patients and their partners) will undergo three non-drug preparatory therapy sessions, followed by two MDMA-assisted therapy sessions. Each MDMA-assisted therapy session will be followed by five non-drug integrative therapy using CBCT.
Detailed description
Cognitive-Behavioral Conjoint Therapy (CBCT) for PTSD is a three-phase, 15-session, manualized treatment. This Phase 1/2 open-label study will combine methods for conducting MDMA-assisted therapy with methods from the CBCT for PTSD in order to treat 10 participants with chronic PTSD and their partners (intimate or non-intimate significant other who does not have a current diagnosis of PTSD) in order to explore whether combined treatment is effective. Each therapy team will have one therapist trained and experienced in MDMA-assisted therapy and one therapist trained and experienced in CBCT. During the first experimental session, both participants will receive 75 mg of midomafetamine HCl followed 1.5 to 2 hours later by an optional supplemental half-dose of 37.5 mg. During the second experimental session, an initial dose of either 100 or 75 mg of midomafetamine HCl will be administered to both participants followed by an optional supplemental half-dose of either 50 mg or 37.5 mg. The primary objective of this study is to assess changes in PTSD symptoms from Baseline to Primary Endpoint in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity scores in PTSD participants.
Interventions
BEHAVIORALCBCT
A three-phase, 15-session, manualized treatment from the CBCT manual
BEHAVIORALTherapy
Manualized MDMA-assisted therapy
DRUGMDMA
Two sessions of MDMA-assisted therapy, one with an initial dose of 75 mg midomafetamine HCl (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg midomafetamine HCl (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
Sponsors
Lykos Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All inclusion criteria for the PTSD and Concerned Significant Other (CSO) are identical except for first two items, marked below: * PTSD+ participant: Meet DSM-5 criteria for current PTSD and satisfies PTSD criteria via CAPS * CSO participant: Meet criteria for V62.89 Other Problem Related to Psychosocial Circumstances under Diagnostic and Statistical Manual 5 (DSM-5), as determined through clinical interview, for current psychosocial circumstances contributing to relationship distress with intimate or non-intimate partner * Are at least 18 years old * If in psychotherapy, willing and able to maintain that schedule without changing it * Are willing to refrain from taking any psychiatric medications during the study period, with the exception of gabapentin when prescribed for pain control. * Willing to remain overnight at the study site * Are willing to be driven home the morning after the experimental sessions, after the integrative therapy session * Are willing to commit to medication dosing, experimental sessions, follow-up sessions, to complete evaluation instruments and commit to be contacted for all necessary telephone contacts * Are willing to remain overnight at the study site after each experimental session until after the integrative session occurring the next morning * Must have a negative pregnancy test at study entry and prior to each experimental session if able to bear children, and must agree to use adequate birth control through 10 days after the last dose of MDMA. * Must provide a contact (relative, spouse, close friend or other caregiver other than the CSO participant) who is willing and able to be reached by the Clinical Investigators in the event of a participant becoming suicidal. * Must agree to inform the Clinical Investigators within 48 hours of any medical conditions and procedures * Are proficient in speaking and reading English * Agree to have all clinic visit and Integrative Sessions recorded to audio and video * Agree to not participate in any other interventional clinical trials during the duration of this study
Exclusion criteria
* The following exclusions are identical for PTSD+ and CSO participants except for the following, marked below: * CSO participant only: Have diagnosis of current PTSD not in remission * Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control * Have evidence or history of significant medical disorders * Have hypertension * Have liver disease; asymptomatic participants with Hepatitis C who have previously undergone evaluation and successful treatment is permitted. * History of hyponatremia or hyperthermia * Weigh less than 48 kg * Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the MDMA-assisted session * Are not able to give adequate informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score | Primary Endpoint (Visit 16, approximately 2 months later) | The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. |
| Change From Baseline to Primary Endpoint CAPS-5 Total Severity Score | Baseline to Primary Endpoint (Visit 16, approximately 2 months later) | The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Patient Beck Depression Inventory-II (BDI-II) | Baseline (screening) | BDI-II is a 21-item self reported instrument used to measure severity of depressive symptoms. 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 scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms. |
| Primary Endpoint Patient Beck Depression Inventory-II (BDI-II) | Primary Endpoint (Visit 16, approximately 2 months later) | BDI-II is a 21-item self reported instrument used to measure severity of depressive symptoms. 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 scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms. |
| Baseline Patient Couples Satisfaction Index (CSI) | Baseline (screening) | The Couples Satisfaction Index (CSI) is a self-reported 32-item scale measuring one's satisfaction in a relationship. Questions discuss overall happiness in relationship, extent of agreement/ disagreement between partners, and feelings towards relationships and are scored on a likert scale from 0 to 5, with higher scores indicating higher satisfaction in the relationship. Scores range from 0 to 160. |
| Primary Endpoint Patient Couples Satisfaction Index (CSI) | Primary Endpoint (Visit 16, approximately 2 months later) | The Couples Satisfaction Index (CSI) is a self-reported 32-item scale measuring one's satisfaction in a relationship. Questions discuss overall happiness in relationship, extent of agreement/ disagreement between partners, and feelings towards relationships and are scored on a likert scale from 0 to 5, with higher scores indicating higher satisfaction in the relationship. Scores range from 0 to 160. |
| Baseline Partner Couples Satisfaction Index (CSI) | Baseline (screening) | The Couples Satisfaction Index (CSI) is a self-reported 32-item scale measuring one's satisfaction in a relationship. Questions discuss overall happiness in relationship, extent of agreement/ disagreement between partners, and feelings towards relationships and are scored on a likert scale from 0 to 5, with higher scores indicating higher satisfaction in the relationship. Scores range from 0 to 160. |
| Primary Endpoint Partner Couples Satisfaction Index (CSI) | Primary Endpoint (Visit 16, approximately 2 months later) | The Couples Satisfaction Index (CSI) is a self-reported 32-item scale measuring one's satisfaction in a relationship. Questions discuss overall happiness in relationship, extent of agreement/ disagreement between partners, and feelings towards relationships and are scored on a likert scale from 0 to 5, with higher scores indicating higher satisfaction in the relationship. Scores range from 0 to 160. |
| Baseline Trauma and Attachment Beliefs Scale (TABS) | Baseline (screening) | TABS is a 84-item self-report scale, which measures responses on a 1 to 6 scale (1 = Disagree Strongly, 6 = Agree Strongly) the degree to which respondents believe the statements correspond with their own beliefs. The measures of these beliefs relate to self-safety, other-safety, self-trust, other-trust, self-esteem, other-esteem, self-intimacy, other-intimacy, self-control, and other control. A TABS total score is calculated by summing all of the items (range 84 to 504). Higher scores indicate greater disruption. |
| Primary Endpoint Trauma and Attachment Beliefs Scale (TABS) | Primary Endpoint (Visit 16, approximately 2 months later) | TABS is a 84-item self-report scale, which measures responses on a 1 to 6 scale (1 = Disagree Strongly, 6 = Agree Strongly) the degree to which respondents believe the statements correspond with their own beliefs. The measures of these beliefs relate to self-safety, other-safety, self-trust, other-trust, self-esteem, other-esteem, self-intimacy, other-intimacy, self-control, and other control. A TABS total score is calculated by summing all of the items (range 84 to 504). Higher scores indicate greater disruption. |
| Baseline Pittsburgh Sleep Quality Index (PSQI) | Baseline (screening) | Self-reported questionnaire that assesses sleep quality and disturbances. The index looks at subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The component scores yield a total score which ranges 0-21 with a higher score indicating worse sleep quality. |
| Primary Endpoint Emotion Regulation Questionnaire (ERQ) Reappraisal Subscale | Primary Endpoint (Visit 16, approximately 2 months later) | ERQ measures self-reported emotional regulation and includes 10 items to assess means of coping with emotions via regulating them through reappraisal or suppression. Items range from 1 (strongly disagree) to 7 (strongly agree). Six of the items are summed to create the reappraisal total score, with total scores ranging from 6 to 42. Higher scores indicate greater emotional reappraisal. |
| Baseline Emotion Regulation Questionnaire (ERQ) Suppression Subscale | Baseline (screening) | ERQ measures self-reported emotional regulation and includes 10 items to assess means of coping with emotions via regulating them through reappraisal or suppression. Items range from 1 (strongly disagree) to 7 (strongly agree). Four of the items are summed to create the suppression total score, with total scores ranging from 4 to 28. Higher scores indicate greater emotional suppression. |
| Primary Endpoint Emotion Regulation Questionnaire (ERQ) Suppression Subscale | Primary Endpoint (Visit 16, approximately 2 months later) | ERQ measures self-reported emotional regulation and includes 10 items to assess means of coping with emotions via regulating them through reappraisal or suppression. Items range from 1 (strongly disagree) to 7 (strongly agree). Four of the items are summed to create the suppression total score, with total scores ranging from 4 to 28. Higher scores indicate greater emotional suppression. |
| Baseline Patient PTSD Checklist-5 (PCL-5) | Baseline (screening) | The PTSD Checklist-5 (PCL-5) is a 20-item self-reported questionnaire that follows DSM-5 criteria to assess PTSD presence and severity. Item scores range from 0 (not at all) to 4 (extremely). A total symptom severity score is determined by summing all items (range 0 to 80). A higher score indicates greater PTSD symptom severity. |
| Primary Endpoint Patient PTSD Checklist-5 (PCL-5) | Primary Endpoint (Visit 16, approximately 2 months later) | The PTSD Checklist-5 (PCL-5) is a 20-item self-reported questionnaire that follows DSM-5 criteria to assess PTSD presence and severity. Item scores range from 0 (not at all) to 4 (extremely). A total symptom severity score is determined by summing all items (range 0 to 80). A higher score indicates greater PTSD symptom severity. |
| Baseline Partner-rated PTSD Checklist-5 (PCL-5) | Baseline (screening) | The PTSD Checklist-5 (PCL-5) is a 20-item self-reported questionnaire that follows DSM-5 criteria to assess PTSD presence and severity. Item scores range from 0 (not at all) to 4 (extremely). A total symptom severity score is determined by summing all items (range 0 to 80). A higher score indicates greater PTSD symptom severity. |
| Primary Endpoint Partner-rated PTSD Checklist-5 (PCL-5) | Primary Endpoint (Visit 16, approximately 2 months later) | The PTSD Checklist-5 (PCL-5) is a 20-item self-reported questionnaire that follows DSM-5 criteria to assess PTSD presence and severity. Item scores range from 0 (not at all) to 4 (extremely). A total symptom severity score is determined by summing all items (range 0 to 80). A higher score indicates greater PTSD symptom severity. |
| Baseline Emotion Regulation Questionnaire (ERQ) Reappraisal Subscale | Baseline (screening) | ERQ measures self-reported emotional regulation and includes 10 items to assess means of coping with emotions via regulating them through reappraisal or suppression. Items range from 1 (strongly disagree) to 7 (strongly agree). Six of the items are summed to create the reappraisal total score, with total scores ranging from 6 to 42. Higher scores indicate greater emotional reappraisal. |
| Primary Endpoint Pittsburgh Sleep Quality Index (PSQI) | Primary Endpoint (Visit 16, approximately 2 months later) | Self-reported questionnaire that assesses sleep quality and disturbances. The index looks at subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The component scores yield a total score which ranges 0-21 with a higher score indicating worse sleep quality. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient MDMA and CBCT Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual) | 6 |
| Partner MDMA and CBCT Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted psychotherapy.
MDMA: Two sessions of MDMA-assisted psychotherapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
CBCT: A three-phase, 15-session, manualized treatment from the CBCT manual
Therapy: Non-directive therapy (from MAPS MDMA-assisted therapy treatment manual) | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Patient MDMA and CBCT | Partner MDMA and CBCT | Total |
|---|---|---|---|
| Age, Continuous | 47.1 years STANDARD_DEVIATION 12.54 | 46.5 years STANDARD_DEVIATION 11.17 | 46.8 years STANDARD_DEVIATION 11.33 |
| Baseline Global CAPS-5 Total Severity Score | 42.0 units on a scale STANDARD_DEVIATION 5.76 | — | 42.0 units on a scale STANDARD_DEVIATION 5.76 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 6 / 6 | 6 / 6 | 2 / 6 | 2 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Change From Baseline to Primary Endpoint CAPS-5 Total Severity Score
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Time frame: Baseline to Primary Endpoint (Visit 16, approximately 2 months later)
Population: PTSD Patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Change From Baseline to Primary Endpoint CAPS-5 Total Severity Score | -25.7 score on a scale | Standard Deviation 13.89 |
Primary
Primary Endpoint Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
Population: PTSD patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Primary Endpoint Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score | 16.3 score on a scale | Standard Deviation 13.71 |
Secondary
Baseline Emotion Regulation Questionnaire (ERQ) Reappraisal Subscale
ERQ measures self-reported emotional regulation and includes 10 items to assess means of coping with emotions via regulating them through reappraisal or suppression. Items range from 1 (strongly disagree) to 7 (strongly agree). Six of the items are summed to create the reappraisal total score, with total scores ranging from 6 to 42. Higher scores indicate greater emotional reappraisal.
Time frame: Baseline (screening)
Population: PTSD patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Baseline Emotion Regulation Questionnaire (ERQ) Reappraisal Subscale | 21.77 score on a scale | Standard Deviation 7.92 |
Secondary
Baseline Emotion Regulation Questionnaire (ERQ) Suppression Subscale
ERQ measures self-reported emotional regulation and includes 10 items to assess means of coping with emotions via regulating them through reappraisal or suppression. Items range from 1 (strongly disagree) to 7 (strongly agree). Four of the items are summed to create the suppression total score, with total scores ranging from 4 to 28. Higher scores indicate greater emotional suppression.
Time frame: Baseline (screening)
Population: PTSD patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Baseline Emotion Regulation Questionnaire (ERQ) Suppression Subscale | 18.96 score on a scale | Standard Deviation 6.28 |
Secondary
Baseline Partner Couples Satisfaction Index (CSI)
The Couples Satisfaction Index (CSI) is a self-reported 32-item scale measuring one's satisfaction in a relationship. Questions discuss overall happiness in relationship, extent of agreement/ disagreement between partners, and feelings towards relationships and are scored on a likert scale from 0 to 5, with higher scores indicating higher satisfaction in the relationship. Scores range from 0 to 160.
Time frame: Baseline (screening)
Population: PTSD patient's partner
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Baseline Partner Couples Satisfaction Index (CSI) | 98.1 score on a scale | Standard Deviation 50.81 |
Secondary
Baseline Partner-rated PTSD Checklist-5 (PCL-5)
The PTSD Checklist-5 (PCL-5) is a 20-item self-reported questionnaire that follows DSM-5 criteria to assess PTSD presence and severity. Item scores range from 0 (not at all) to 4 (extremely). A total symptom severity score is determined by summing all items (range 0 to 80). A higher score indicates greater PTSD symptom severity.
Time frame: Baseline (screening)
Population: PTSD patient's partner
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Baseline Partner-rated PTSD Checklist-5 (PCL-5) | 49.58 score on a scale | Standard Deviation 8.52 |
Secondary
Baseline Patient Beck Depression Inventory-II (BDI-II)
BDI-II is a 21-item self reported instrument used to measure severity of depressive symptoms. 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 scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms.
Time frame: Baseline (screening)
Population: PTSD patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Baseline Patient Beck Depression Inventory-II (BDI-II) | 32.91 score on a scale | Standard Deviation 8.75 |
Secondary
Baseline Patient Couples Satisfaction Index (CSI)
The Couples Satisfaction Index (CSI) is a self-reported 32-item scale measuring one's satisfaction in a relationship. Questions discuss overall happiness in relationship, extent of agreement/ disagreement between partners, and feelings towards relationships and are scored on a likert scale from 0 to 5, with higher scores indicating higher satisfaction in the relationship. Scores range from 0 to 160.
Time frame: Baseline (screening)
Population: PTSD patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Baseline Patient Couples Satisfaction Index (CSI) | 105.37 score on a scale | Standard Deviation 13.39 |
Secondary
Baseline Patient PTSD Checklist-5 (PCL-5)
The PTSD Checklist-5 (PCL-5) is a 20-item self-reported questionnaire that follows DSM-5 criteria to assess PTSD presence and severity. Item scores range from 0 (not at all) to 4 (extremely). A total symptom severity score is determined by summing all items (range 0 to 80). A higher score indicates greater PTSD symptom severity.
Time frame: Baseline (screening)
Population: PTSD patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Baseline Patient PTSD Checklist-5 (PCL-5) | 62.64 score on a scale | Standard Deviation 6.35 |
Secondary
Baseline Pittsburgh Sleep Quality Index (PSQI)
Self-reported questionnaire that assesses sleep quality and disturbances. The index looks at subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The component scores yield a total score which ranges 0-21 with a higher score indicating worse sleep quality.
Time frame: Baseline (screening)
Population: PTSD patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Baseline Pittsburgh Sleep Quality Index (PSQI) | 14.24 score on a scale | Standard Deviation 3.54 |
Secondary
Baseline Trauma and Attachment Beliefs Scale (TABS)
TABS is a 84-item self-report scale, which measures responses on a 1 to 6 scale (1 = Disagree Strongly, 6 = Agree Strongly) the degree to which respondents believe the statements correspond with their own beliefs. The measures of these beliefs relate to self-safety, other-safety, self-trust, other-trust, self-esteem, other-esteem, self-intimacy, other-intimacy, self-control, and other control. A TABS total score is calculated by summing all of the items (range 84 to 504). Higher scores indicate greater disruption.
Time frame: Baseline (screening)
Population: PTSD patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Baseline Trauma and Attachment Beliefs Scale (TABS) | 289.78 score on a scale | Standard Deviation 44.3 |
Secondary
Primary Endpoint Emotion Regulation Questionnaire (ERQ) Reappraisal Subscale
ERQ measures self-reported emotional regulation and includes 10 items to assess means of coping with emotions via regulating them through reappraisal or suppression. Items range from 1 (strongly disagree) to 7 (strongly agree). Six of the items are summed to create the reappraisal total score, with total scores ranging from 6 to 42. Higher scores indicate greater emotional reappraisal.
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
Population: PTSD patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Primary Endpoint Emotion Regulation Questionnaire (ERQ) Reappraisal Subscale | 28.34 score on a scale | Standard Deviation 2.3 |
Secondary
Primary Endpoint Emotion Regulation Questionnaire (ERQ) Suppression Subscale
ERQ measures self-reported emotional regulation and includes 10 items to assess means of coping with emotions via regulating them through reappraisal or suppression. Items range from 1 (strongly disagree) to 7 (strongly agree). Four of the items are summed to create the suppression total score, with total scores ranging from 4 to 28. Higher scores indicate greater emotional suppression.
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
Population: PTSD patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Primary Endpoint Emotion Regulation Questionnaire (ERQ) Suppression Subscale | 13.63 score on a scale | Standard Deviation 5.41 |
Secondary
Primary Endpoint Partner Couples Satisfaction Index (CSI)
The Couples Satisfaction Index (CSI) is a self-reported 32-item scale measuring one's satisfaction in a relationship. Questions discuss overall happiness in relationship, extent of agreement/ disagreement between partners, and feelings towards relationships and are scored on a likert scale from 0 to 5, with higher scores indicating higher satisfaction in the relationship. Scores range from 0 to 160.
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
Population: PTSD patient's partner
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Primary Endpoint Partner Couples Satisfaction Index (CSI) | 125.34 score on a scale | Standard Deviation 30.59 |
Secondary
Primary Endpoint Partner-rated PTSD Checklist-5 (PCL-5)
The PTSD Checklist-5 (PCL-5) is a 20-item self-reported questionnaire that follows DSM-5 criteria to assess PTSD presence and severity. Item scores range from 0 (not at all) to 4 (extremely). A total symptom severity score is determined by summing all items (range 0 to 80). A higher score indicates greater PTSD symptom severity.
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
Population: PTSD patient's partner
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Primary Endpoint Partner-rated PTSD Checklist-5 (PCL-5) | 21.54 score on a scale | Standard Deviation 19.67 |
Secondary
Primary Endpoint Patient Beck Depression Inventory-II (BDI-II)
BDI-II is a 21-item self reported instrument used to measure severity of depressive symptoms. 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 scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms.
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
Population: PTSD patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Primary Endpoint Patient Beck Depression Inventory-II (BDI-II) | 12.75 score on a scale | Standard Deviation 16.88 |
Secondary
Primary Endpoint Patient Couples Satisfaction Index (CSI)
The Couples Satisfaction Index (CSI) is a self-reported 32-item scale measuring one's satisfaction in a relationship. Questions discuss overall happiness in relationship, extent of agreement/ disagreement between partners, and feelings towards relationships and are scored on a likert scale from 0 to 5, with higher scores indicating higher satisfaction in the relationship. Scores range from 0 to 160.
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
Population: PTSD patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Primary Endpoint Patient Couples Satisfaction Index (CSI) | 127.00 score on a scale | Standard Deviation 34.34 |
Secondary
Primary Endpoint Patient PTSD Checklist-5 (PCL-5)
The PTSD Checklist-5 (PCL-5) is a 20-item self-reported questionnaire that follows DSM-5 criteria to assess PTSD presence and severity. Item scores range from 0 (not at all) to 4 (extremely). A total symptom severity score is determined by summing all items (range 0 to 80). A higher score indicates greater PTSD symptom severity.
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
Population: PTSD patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Primary Endpoint Patient PTSD Checklist-5 (PCL-5) | 23.96 score on a scale | Standard Deviation 19.08 |
Secondary
Primary Endpoint Pittsburgh Sleep Quality Index (PSQI)
Self-reported questionnaire that assesses sleep quality and disturbances. The index looks at subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The component scores yield a total score which ranges 0-21 with a higher score indicating worse sleep quality.
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
Population: PTSD patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Primary Endpoint Pittsburgh Sleep Quality Index (PSQI) | 10.37 score on a scale | Standard Deviation 4.49 |
Secondary
Primary Endpoint Trauma and Attachment Beliefs Scale (TABS)
TABS is a 84-item self-report scale, which measures responses on a 1 to 6 scale (1 = Disagree Strongly, 6 = Agree Strongly) the degree to which respondents believe the statements correspond with their own beliefs. The measures of these beliefs relate to self-safety, other-safety, self-trust, other-trust, self-esteem, other-esteem, self-intimacy, other-intimacy, self-control, and other control. A TABS total score is calculated by summing all of the items (range 84 to 504). Higher scores indicate greater disruption.
Time frame: Primary Endpoint (Visit 16, approximately 2 months later)
Population: PTSD patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MDMA (75 mg or 100 mg) + CBCT | Primary Endpoint Trauma and Attachment Beliefs Scale (TABS) | 232.7 score on a scale | Standard Deviation 69.07 |