ACTRN12623000832673招募中1 期
Investigating the safety, feasibility and acceptability of psilocybin-assisted psychotherapy in treatment resistant depression.
St. Vincent's Hospital, Sydney0 个研究点目标入组 20 人开始时间: 2023年8月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •· Male and female participants 18 - 75 years of age.
- •· Have given written informed consent.
- •· Currently under the care of a psychiatrist who is able to provide a referral and willing to maintain ongoing oversight of their patient’s clinical care and treatment management throughout the duration of the study.
- •· Have a DSM-5 diagnosis of Major Depressive Disorder and currently experiencing a major depressive episode, as confirmed by the study psychiatrist.
- •· Failed to clinically respond to two different classes of antidepressant medication treatment (despite adequate dose compliance and minimum treatment duration of 6 weeks) during the current major depressive episode.
- •· Have baseline MADRS score greater than or equal to 20.
- •· Able to maintain stable psychotropic medications (including stable dose) from time of first psilocybin dose to last psilocybin dose, and at a dose not exceeding the recommended upper dose limit according to the Australian Medicines Handbook.
- •· Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least 4 weeks prior to screening and is expected to remain stable until the final dose of psilocybin.
- •· Will have accompanied transport home after treatment sessions and availability of a friend or family member and home-like environment for the 24 hours following psilocybin dosing.
- •· Able to engage with psychotherapy.
- •· Able to be followed up for entire duration of the study (i.e., planning to remain in Sydney for the duration of the study).
- •· In good general medical health as confirmed by study doctor assessment supported with information from GP/referring psychiatrist.
- •· Agree to refrain from using any alcoholic beverages or nicotine, within 24 hours of each drug administration. The exception is caffeine.
- •· Agree to only take medications on the mornings of drug sessions that have been approved by the study psychiatrist.
- •· Agree to refrain from taking any non-prescription drugs, nutritional supplements, or herbal supplements for one week before each psilocybin administration unless approved by the study psychiatrist.
- •· Have none or limited lifetime use of hallucinogens (none in last 12 months).
- •· Worked or studied in a context requiring some proficiency in spoken English (to ensure validity of neuropsychological testing).
- •· Adequate clinical, ongoing support from own treating psychiatrist and other mental health clinicians, including safety plan in the event of becoming acutely suicidal, as determined by the study psychiatrist.
排除标准
- •· Women who are pregnant, intend to become pregnant during the study or who are currently nursing.
- •· Have any significant cardiovascular conditions including uncontrolled hypertension.
- •· Have epilepsy or a history of seizures.
- •· Have history of any substance use disorder (except nicotine or caffeine) within the past 12 months.
- •· Currently taking MAOIs, lithium or any other medication that may interfere with the study drug as determined by the study psychiatrist.
- •· Current or lifetime history of meeting DSM-5 criteria for any psychotic disorders (including mood disorders with psychotic features), or bipolar I or II disorder.
- •· Have a known first or second-degree relative with any psychotic disorder, or bipolar I or II disorder.
- •· Significant suicide risk within the past year, as judged by study psychiatrist and informed by C-SSRS.
- •· Have any condition preventing establishment of rapport and safe psilocybin treatment, as determined by the study psychiatrist.
研究者
相似试验
已完成
不适用
To explore safety and feasibility of mobile teledermoscopy for Queensland residents 50-64 year of age at high risk for melanoma.Skin CancerMelanomaCancer - Malignant melanomaMelanomaSkin CancerACTRN12613000590763Queensland University of Technology (QUT), Institute of Health and Biomedical Innovation (IHBI)50
尚未招募
4 期
Transplantation and Diabetes (Transdiab): A Pilot Randomised Controlled Trial of Metformin in pre-diabetes after kidney transplantatioew onset diabetes after kidney transplantatonNew onset diabetes after kidney transplantatonRenal and Urogenital - Kidney diseaseMetabolic and Endocrine - DiabetesACTRN12614001171606Auckland District Health Board200
尚未招募
Unknown
Safety and Efficacy of Glucagon-like peptide 1 agonists in dialysis patientsEnd stage kidney diseaseRenal and Urogenital - Kidney diseaseMetabolic and Endocrine - DiabetesDiabetesACTRN12623000862640Auckland City Hospital95
已完成
不适用
A feasibility study investigating the safety, performance and gastrointestinal transit of the DV3395 device concept in healthy participants.NL-OMON50389ovo Nordisk65
尚未招募
不适用
A Study To Evaluate The Safety And Feasibility Of Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO) In Patients With Coronary Artery Disease Undergoing Native Vessel InterventioCoronary Artery DiseaseCoronary Atherosclerosis10011082NL-OMON34428Miracor medical systems10