EUCTR2018-001718-13-CZ进行中（未招募）1 期
An Open- Label, Phase 2, Multicenter Feasibility Study if Manualized MDMA-Assisted Psychotherapy with an fMRI sub-study Assessing Changes in Brain Activity in Subjects with Posttraumatic Stress Disorder.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Are at least 18 years old
- •-Are fluent in speaking and reading the predominantly used or recognized language of the study site
- •-Are able to swallow pills
- •-Agree to have study visits video-recorded, including Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions
- •-Must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable
- •-Must agree to inform the investigators within 48 hours of any medical treatments and procedures
- •-Women of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile), must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session. Adequate birth control methods include intrauterine device (IUD), injected or implanted hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). Not of childbearing potential is defined as permanent sterilization, postmenopausal, or assigned male at birth.
- •-Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not participate in any other interventional clinical trials during the duration of the study, remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures
- •- At Screening, meet DSM-5 criteria for current PTSD
- •- At Screening, have at least severe PTSD
- •- May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease
- •- May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.
- •For MRI sub-study
- •- Absence of Traumatic Brain Injury
- •- Absence of metal implants or metal fragments in the body
- •- PTSD must be of non-dissociative sub-type
- •- Absence of claustrophobia
- •- Absence of tattoos in the head/neck or permanent eye makeup
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •- Are not able to give adequate informed consent
- •- Have any current problem which, in the opinion of the investigator or
- •Medical Monitor, might interfere with participation
- •- Would present a serious risk to others as established through clinical
- •interview and contact with treating psychiatrist
- •- Require ongoing concomitant therapy with a psychiatric medication
- •with exceptions described in the protocol.
- •- Weigh less than 48 kilograms (kg)
- •- Are pregnant or nursing or are of childbearing potential and are not
- •practicing an effective means of birth control.
研究者
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