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

Arq National Psychotrauma Centre0 sites20 target enrollmentJanuary 8, 2024

Overview

No summary available.

Registry

who.int

Start Date

January 8, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Arq National Psychotrauma Centre

•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.

•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.