MDMA-assisted therapy for adolescents with treatment-resistant PTSD
EU CTIS ID: 2024-515184-65-01
What this study is testing
To assess the feasibility and safety of MDMA-assisted therapy for adolescents (16 through 18 years old) with treatment-resistant PTSD.
- 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
- Is 16 through 18 years of age.
- Meets criteria for PTSD according to the CAPS-CA-5.
- Has previously followed at least one evidence-based treatment programs without significant symptom reduction.
- Has a social support system, such as parents, foster parents, or mentor, in place that is willing and able to participate.
- Is in adequate safety during the trial (e.g., a stable place to live, no ongoing stalking).
- Is willing to establish and commit to a plan for post-treatment care with current referrer.
You likely can't join if
- Inability to speak and write Dutch.
- Known hypersensitivity to MDMA or to any of the excipients of the investigational medicinal product.
- Recreational MDMA use within 3 months before the first MDMA-assisted session.
- Sexually active females who are not practicing an effective means of birth control and pregnant females.
- Evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder.
- Acute suicidality, psychotic problems, bipolar disorder, or substance use disorder.
See the full eligibility criteria
- Is 16 through 18 years of age.
- Meets criteria for PTSD according to the CAPS-CA-5.
- Has previously followed at least one evidence-based treatment programs without significant symptom reduction.
- Has a social support system, such as parents, foster parents, or mentor, in place that is willing and able to participate.
- Is in adequate safety during the trial (e.g., a stable place to live, no ongoing stalking).
- Is willing to establish and commit to a plan for post-treatment care with current referrer.
- Provides written informed consent
- Inability to speak and write Dutch.
- Known hypersensitivity to MDMA or to any of the excipients of the investigational medicinal product.
- Recreational MDMA use within 3 months before the first MDMA-assisted session.
- Sexually active females who are not practicing an effective means of birth control and pregnant females.
- Evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder.
- Acute suicidality, psychotic problems, bipolar disorder, or substance use disorder.
- Any of the following cardiovascular conditions: hypertension, coronary artery disease, pe-ripheral vascular disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ische-mia, congestive heart failure, tachycardia, artificial heart valve, or any other significant car-diovascular condition.
- Estimated or determined intellectual disability (IQ <70).
- Suffering from ongoing trauma by a parent who is part of the adolescent’s current primary-care system.
- Have any current problem which, in the opinion of the investigator or medical staff, might interfere with participation.
- Pregnant or breastfeeding, or a positive urine pregnancy test at screening for participants who are able to become pregnant.
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, 0-17 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.