The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. It contains symptom subscales, a CAPS-IV total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. The dichotomous diagnostic score is based upon meeting each of five criteria, including index trauma, presence or absence of Criteria B, C, D described above, duration of symptoms and distress and is scored as meeting versus not meeting criteria for diagnosis.
Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD
Brief Summary
Intervention / Treatment
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MDMA (DRUG)3,4-methylenedioxymethamphetamine
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Psychotherapy (BEHAVIORAL)Standardized non-directive psychotherapy performed by therapist team
Condition or Disease
- PTSD
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Recruiting |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 60 (ESTIMATED) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
Masking |
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Clinical Trial Dates
| Start date: | Nov 08, 2021 | ACTUAL |
|---|---|---|
| Primary Completion: | Jul 01, 2025 | ESTIMATED |
| Completion Date: | Jul 01, 2025 | ESTIMATED |
| Study First Posted: | Mar 05, 2021 | ACTUAL |
| Last Updated: | Sep 19, 2023 |
Sponsors / Collaborators
Location
Participant Groups
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Two Experimental Sessions of MDMA-assisted Psychotherapy
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Three Experimental Sessions of MDMA-assisted Psychotherapy
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
* Are at least 18 years old.
* Are fluent in speaking and reading the predominantly used or recognized language of the study site.
* Are able to swallow pills.
* Agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions.
* Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
* Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
* If of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session.
* Must not participate in any other interventional clinical trials during the duration of the study.
* Must be willing to remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures.
* At baseline, have moderate PTSD diagnosis.
Exclusion Criteria:
* Are not able to give adequate informed consent.
* Have uncontrolled hypertension.
* Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds \[ms\] corrected by Bazett's formula).
* Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
* Have evidence or history of significant medical disorders.
* Have symptomatic liver disease.
* Have history of hyponatremia or hyperthermia.
* Weigh less than 48 kilograms (kg).
* Are pregnant or nursing, or are of childbearing potential and are not practicing an effective means of birth control.
* Are abusing illegal drugs.
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Primary Outcomes
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The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. It contains symptom subscales, a CAPS-IV total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. The dichotomous diagnostic score is based upon meeting each of five criteria, including index trauma, presence or absence of Criteria B, C, D described above, duration of symptoms and distress and is scored as meeting versus not meeting criteria for diagnosis.
Secondary Outcomes
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Sheehan Disability Scale (SDS) total score, a measure of clinician-rated functional impairment. The items indicate degree of impairment in the domains of work/school, social life, and home life, with response options based on an eleven-point scale (0=not at all to 10=extremely), and five verbal tags (not at all, mildly, moderately, markedly, extremely).
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Sheehan Disability Scale (SDS) total score, a measure of clinician-rated functional impairment. The items indicate degree of impairment in the domains of work/school, social life, and home life, with response options based on an eleven-point scale (0=not at all to 10=extremely), and five verbal tags (not at all, mildly, moderately, markedly, extremely).
More Details
| NCT Number: | NCT04784143 |
|---|---|
| Acronym: | MPVA6 |
| Other IDs: | MPVA6 |
| Study URL: | https://clinicaltrials.gov/study/NCT04784143 |