ACTRN12622001525774招募中2 期
Developing Optimal Psychedelic Assisted Psychotherapy: Investigating the Effect on Symptom Severity for Adults with Obsessive-Compulsive Disorder
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Diagnosis of Obsessive-Compulsive Disorder, in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5)
- •18-65 years of age.
- •Treatment resistant symptoms:
- •For OCD: failure to tolerate or respond to at least 2 trials of adequate medication therapy (SSRI or clomipramine) at minimum effective therapeutic dose for at least 8 weeks
- •Moderate – severe symptoms:
- •For OCD: YBOCS score of >13
- •Demonstrated capacity to give informed consent
- •Willingness and capacity (as judged on assessment by study clinicians) to engage in the therapeutic elements of the study protocol
排除标准
- •Participants who are not able to give adequate informed consent.
- •Current or previously diagnosed psychotic disorder, schizophrenia or bipolar disorder
- •Immediate family member with a diagnosed psychotic disorder
- •Significant history of mania.
- •Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure)
- •History of serious suicide attempts in recent years requiring hospitalisation as judged by a study psychiatrist at initial assessment to impact on safety of participation.
- •Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin / MDMA, e.g., borderline personality disorder
- •Positive pregnancy test at screening or during the study, women who are planning a pregnancy and/or women who are nursing/breastfeeding.
- •Participants who do not agree to use an acceptable contraceptive method throughout their participation in the study.
- •Current drug or alcohol dependence
- •Recreational use in last 12 months of psychedelic substances or a history of regular psychedelic use
- •No email access/ability or no willingness to engage in follow up by electronic questionnaires
- •Use of contraindicated medication (outlined further below) including MAOI, SSRI or SNRI: SSRI/SNRI withdrawal for at least one week (4 weeks for fluoxetine), 2 weeks for irreversible MAOI
- •Use within 5 half-lives of any other serotonin-enhancing medication
- •Participants presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 440ms for men and above 470ms for women)
- •Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.
- •Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
- •BMI <17 or >42
- •Participants with significant difficulties in English comprehension or communication.
研究者
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