BridgeMD
High-Intensity Inpatient MDMA-Assisted Psychotherapy for Treatment-Refractory Posttraumatic Stress Disorder: An Open-Label Pilot Study
EU CTIS ID: 2023-508229-28-00
What this study is testing
The primary objective of this study is to evaluate the effect of MDMA-assisted therapy on PTSD symptoms.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Have a current Personality Disorder (except for avoidant personality disorder due to the significant overlap with PTSD)
- 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).
See the full eligibility 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.
- Have a current Personality Disorder (except for avoidant personality disorder due to the significant overlap with PTSD)
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.