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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDMA-assisted therapy and CBCT | Experimental | Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDMA | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Primary Endpoint (Visit 16, approximately 2 months later) |
| 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. | Baseline to Primary Endpoint (Visit 16, approximately 2 months later) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael C Mithoefer, MD | Private Practice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Offices of Michael Mithoefer MD | Mt. Pleasant | South Carolina | 29464 | United States |
We plan to share outcome measure data upon request
After study data lock
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | PTSD patient | Posted | Mean | Standard Deviation | score on a scale | Primary Endpoint (Visit 16, approximately 2 months later) |
|
Adverse events were collected from enrollment to study completion (a period of approximately 6 months) and at 6-month follow-up (1 year after enrollment).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PTSD Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose) | Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted therapy. 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Lykos Therapeutics | 877-627-7722 | trialdata@lykospbc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2017 | Oct 29, 2024 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 7, 2018 | Jun 7, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 2, 2015 | Jun 14, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018817 | N-Methyl-3,4-methylenedioxyamphetamine |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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|
|
| CBCT | Behavioral | A three-phase, 15-session, manualized treatment from the CBCT manual |
|
|
| Therapy | Behavioral | Manualized MDMA-assisted therapy |
|
| Baseline (screening) |
| 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. | Primary Endpoint (Visit 16, approximately 2 months later) |
| 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. | Baseline (screening) |
| 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. | Primary Endpoint (Visit 16, approximately 2 months later) |
| 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. | Baseline (screening) |
| 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. | Primary Endpoint (Visit 16, approximately 2 months later) |
| 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. | Baseline (screening) |
| 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. | Primary Endpoint (Visit 16, approximately 2 months later) |
| 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. | Baseline (screening) |
| 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. | Primary Endpoint (Visit 16, approximately 2 months later) |
| 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. | Baseline (screening) |
| 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. | Primary Endpoint (Visit 16, approximately 2 months later) |
| 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. | Baseline (screening) |
| 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. | Primary Endpoint (Visit 16, approximately 2 months later) |
| 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. | Baseline (screening) |
| 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. | Primary Endpoint (Visit 16, approximately 2 months later) |
| 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. | Baseline (screening) |
| 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. | Primary Endpoint (Visit 16, approximately 2 months later) |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline Global CAPS-5 Total Severity Score | Partner does not have PTSD therefore CAPS-5 was not assessed per protocol | Mean | Standard Deviation | units on a scale |
|
|
|
| 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. | PTSD Patient | Posted | Mean | Standard Deviation | score on a scale | Baseline to Primary Endpoint (Visit 16, approximately 2 months later) |
|
|
|
| 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. | PTSD patient | Posted | Mean | Standard Deviation | score on a scale | Baseline (screening) |
|
|
|
| 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. | PTSD patient | Posted | Mean | Standard Deviation | score on a scale | Primary Endpoint (Visit 16, approximately 2 months later) |
|
|
|
| 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. | PTSD patient | Posted | Mean | Standard Deviation | score on a scale | Baseline (screening) |
|
|
|
| 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. | PTSD patient | Posted | Mean | Standard Deviation | score on a scale | Primary Endpoint (Visit 16, approximately 2 months later) |
|
|
|
| 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. | PTSD patient | Posted | Mean | Standard Deviation | score on a scale | Baseline (screening) |
|
|
|
| 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. | PTSD patient | Posted | Mean | Standard Deviation | score on a scale | Primary Endpoint (Visit 16, approximately 2 months later) |
|
|
|
| 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. | PTSD patient's partner | Posted | Mean | Standard Deviation | score on a scale | Baseline (screening) |
|
|
|
| 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. | PTSD patient's partner | Posted | Mean | Standard Deviation | score on a scale | Primary Endpoint (Visit 16, approximately 2 months later) |
|
|
|
| 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. | PTSD patient | Posted | Mean | Standard Deviation | score on a scale | Baseline (screening) |
|
|
|
| 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. | PTSD patient | Posted | Mean | Standard Deviation | score on a scale | Primary Endpoint (Visit 16, approximately 2 months later) |
|
|
|
| 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. | PTSD patient | Posted | Mean | Standard Deviation | score on a scale | Baseline (screening) |
|
|
|
| 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. | PTSD patient | Posted | Mean | Standard Deviation | score on a scale | Primary Endpoint (Visit 16, approximately 2 months later) |
|
|
|
| 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. | PTSD patient | Posted | Mean | Standard Deviation | score on a scale | Baseline (screening) |
|
|
|
| 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. | PTSD patient | Posted | Mean | Standard Deviation | score on a scale | Primary Endpoint (Visit 16, approximately 2 months later) |
|
|
|
| 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. | PTSD patient | Posted | Mean | Standard Deviation | score on a scale | Baseline (screening) |
|
|
|
| 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. | PTSD patient | Posted | Mean | Standard Deviation | score on a scale | Primary Endpoint (Visit 16, approximately 2 months later) |
|
|
|
| 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. | PTSD patient's partner | Posted | Mean | Standard Deviation | score on a scale | Baseline (screening) |
|
|
|
| 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. | PTSD patient's partner | Posted | Mean | Standard Deviation | score on a scale | Primary Endpoint (Visit 16, approximately 2 months later) |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | CSO Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose) | Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted therapy. 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) | 0 | 6 | 0 | 6 | 6 | 6 |
| EG002 | PTSD Patients at 6-month Follow-up | Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted therapy. 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) | 0 | 6 | 0 | 6 | 2 | 6 |
| EG003 | CSO Patients at 6-month Follow-up | Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted therapy. 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) | 0 | 6 | 0 | 6 | 2 | 6 |
| Visual Impairment | Eye disorders | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Asthenia | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Acute sinusitis | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Disturbance in attention | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Paresthesia | Nervous system disorders | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| Abortion, spontaneous | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Tic | Psychiatric disorders | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Urethritis | Infections and infestations | Systematic Assessment |
|
| Tooth infection | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Organic Chemicals |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|