MDMA-assisted therapy for adolescents with treatment-resistant PTSD
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The primary feasibility endpoint is treatment completion, defined as the proportion of participants who complete all three MDMA-assisted sessions and the assessment within one week after the final integration session.
研究概览
简要总结
To assess the feasibility and safety of MDMA-assisted therapy for adolescents (16 through 18 years old) with treatment-resistant PTSD.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Is 16 through 18 years of age.
- •Meets criteria for PTSD according to the CAPS-CA-
- •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
排除标准
- •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.
结局指标
主要结局
The primary feasibility endpoint is treatment completion, defined as the proportion of participants who complete all three MDMA-assisted sessions and the assessment within one week after the final integration session.
The primary feasibility endpoint is treatment completion, defined as the proportion of participants who complete all three MDMA-assisted sessions and the assessment within one week after the final integration session.
Safety will be assessed by the number of adverse events and serious adverse events, and treatment discontinuations until the end of the study.
Safety will be assessed by the number of adverse events and serious adverse events, and treatment discontinuations until the end of the study.
次要结局
- NEQ questionnaire at within one week after the final integration session
- Change in CAPS-CA-5 total score from baseline to within one week after the final integration session.
- Change in PROMIS Anxiety, PROMIS Depression, cPTCI, CYRM-R, WAV-12, Cantril ladder, Resilience Cantril ladder, and EQ-5D from baseline to within one week after the final integration session.
研究者
Josjan Zijlmans
Scientific
Stichting Amsterdam UMC