High-Intensity Inpatient MDMA-Assisted Psychotherapy for Treatment-Refractory Posttraumatic Stress Disorder: An Open-Label Pilot Study

Phase 1

• Conditions: posttraumatic stress disorder; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: CTIS2023-508229-28-00
• Lead Sponsor: Arq National Psychotrauma Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-08
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Are at least 18 years, at the time of signing the informed consent., At Screening meet DSM-5 criteria for current PTSD with a symptom duration of at least 6 months., At Screening, have a PCL-5 score of 40 or greater (i.e., moderate to severe PTSD)., At screening, meet criteria for treatment-refractory PTSD, defined as having had at least two evidence-based trauma focused psychotherapies of at least 10 sessions per therapy.

Exclusion Criteria

Have a current Personality Disorder, Have a diagnosis of uncontrolled hypertension, defined as repeated blood pressure readings of =140 mmHg systolic or =90 mmHg diastolic., Have a current eating disorder with compensatory behaviors, Have current major depressive disorder with psychotic features., Have a history of, or a current primary psychotic disorder or bipolar affective disorder type 1, Have a current moderate (not in early remission in the 3 months prior to enrollment and meets at least 5 of 11 diagnostic criteria per DSM-5) or severe alcohol or cannabis use disorder within the 12 months prior to enrollment (meets at least 6 of 11 diagnostic criteria per DSM-5)., Have an active illicit drug (other than cannabis) or prescription drug substance use disorder at any severity within 12 months prior to enrollment., Any participant presenting current serious suicide risk, as determined through psychiatric interview, responses to C-SSRS, and clinical judgment of the investigator will be excluded; however, history of suicide attempts is not an exclusion., Have a marked baseline QTcF interval >450 ms demonstrated on repeated ECG assessments., Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate. This includes, but is not limited to, a history of myocardial infarction, cerebrovascular accident, heart failure, severe coronary artery disease, or aneurysm.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified