MDMA-assisted therapy for adolescents with treatment-resistant PTSD

Who can take part

• 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

Who cannot take part

• Recreational MDMA use within 3 months before the first MDMA-assisted session
• Known hypersensitivity to MDMA or to any of the excipients of the investigational medicinal product
• 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
• Inability to speak and write Dutch
• Sexually active females who are not practicing an effective means of birth control and pregnant females
• 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