NL-OMON56347招募中2 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 Post-Traumatic Stress Disorder - MDMA-Assisted Psychotherapy for the Treatment of PTSD
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 8
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Are at least 18 years old
- •2. Are fluent in speaking and reading the predominantly used or recognized
- •language of the study site
- •3. Are able to swallow pills
- •4. Agree to have study visits video-recorded, including Experimental Sessions,
- •Independent Rater assessments, and non-drug psychotherapy sessions
- •5. 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
- •6. Must agree to inform the investigators within 48 hours of any medical
- •treatments and procedures
- •7. If of childbearing potential, 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.
- •8. Agree to the following lifestyle modifications (described in more detail in
- •Section 4.3 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
- •9. At Screening, meet DSM-5 criteria for current PTSD with a symptom duration
- •of 6 months or longer
- •10. At Screening, have at least severe PTSD symptoms in the last month based on
- •PCL-5 total score of 50 or greater
- •11. At Screening, 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
- •12. At Screening, may have asymptomatic Hepatitis C virus (HCV) that has
- •previously undergone evaluation and treatment as needed
- •13. At Baseline, have a confirmed diagnosis of PTSD per CAPS-5 and at least
- •severe symptoms in the last month constituting a CAPS-5 Total Severity Score of
- •35 or greater.
- •14. Absence of Traumatic Brain Injury
- •15. Absence of metal implants or metal fragments in the body
- •16. PTSD must be of non-dissociative sub-type
- •17. Absence of claustrophobia
- •18. Absence of tattoos in the head/neck or permanent eye makeup
排除标准
- •1. Are not able to give adequate informed consent
- •2. Are currently engaged in compensation litigation whereby financial gain
- •would be achieved from prolonged symptoms of PTSD or any other psychiatric
- •3. Are likely, in the investigator*s opinion and via observation during the
- •Preparatory Period, to be re-exposed to their index trauma or other significant
- •trauma, lack social support, or lack a stable living situation
- •4. Have used Ecstasy (material represented as containing MDMA) more than 10
- •times within the last 10 years or at least once within 6 months of the first
- •Experimental Session; or have previously participated in a MAPS-sponsored MDMA
- •clinical trial
- •5. Have any current problem which, in the opinion of the investigator or
- •Medical Monitor, might interfere with participation, Psychiatric History, 1.
- •Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment
- •2. Have a history of, or a current primary psychotic disorder, bipolar
- •affective disorder type 1 assessed via MINI or dissociative identity disorder
- •assessed via DDIS
- •3. Have Dissociative Subtype of PTSD assessed via CAPS-5
- •4. Have a current eating disorder with active purging assessed via MINI
- •5. Have current major depressive disorder with psychotic features assessed via
- •6. Meet DSM-5 criteria for current substance use disorder for alcohol or
- •substance use disorder other than caffeine or nicotine assessed via MINI,
- •AUDIT, DUDIT, drug test, and blood %carbohydrate-deficient transferrin (%CDT)
- •7.Have current Personality Disorders (paranoid, schizoid, antisocial,
- •borderline, histrionic, narcissistic, avoidant, dependent,
- •obsessive-compulsive) assessed via CIPD. Diagnoses will be confirmed via
- •clinical interview
- •8. 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. Any participant who is likely to require hospitalization related
- •to suicidal ideation and behavior, in the judgment of the investigator, will
- •not be enrolled
- •9. Would present a serious risk to others as established through clinical
- •interview and contact with treating psychiatrist
- •10. Require ongoing concomitant therapy with a psychiatric medication with
- •exceptions described in Section 12.0: Concomitant Medications., Medical
- •History, 1. Have evidence on clinical examination or history of significant
- •(controlled or uncontrolled) hematological, endocrine, cerebrovascular,
- •traumatic brain injury (TBI) with residual neurological signs or symptoms on
- •the physical exam, cardiovascular, coronary artery disease (using the New York
- •Heart Association criteria) cerebral or peripheral vascular disease, pulmonary,
- •renal, hepatic disease with abnormal liver enzymes (outside of the normal
- •clinical range), gastrointestinal, immunocompromising, or neurological disease,
- •including seizure disorder, or any other medical disorder judged by the
- •investigator to significantly increase the risk of MDMA administration
- •(participants with hypothyroidism who are on adequate and stable thyroid
- •replacement will not be excluded). Note: if participants present with a history
- •of glaucoma, enrollment would be allowed only with the approval of their
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