ACTRN12623000618651招募中1 期
Exploratory trial to assess the efficacy and safety of Psilocybin-Assisted Psychotherapy (PAP) involving family-members compared to standard PAP, in adults with treatment-resistant major depressive disorder. (TRMDD).
Reset Mind Science0 个研究点目标入组 60 人开始时间: 2023年6月6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
- 60
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
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Participant must be over 18 years of age inclusive, up to 65 years old at
- •the time of signing the informed consent.
- •Participant is able to read, understand and agree with the procedures of
- •Participants must be diagnosed with major depressive disorder and have
- •moderate to severe depression (17+ on the 17-item Hamilton Depression
- •Rating scale [HAM-D17]).
- •Participants have failed to respond to two adequate courses of
- •antidepressant treatment of different pharmacological classes lasting at least
- •6 weeks within the current depressive episode and have not been subject to
- •Electroconvulsive therapy (ECT) within 6 months prior to the study.
- •Participants can confirm the involvement and willingness of a family
- •member during the PAP sessions and duration of the study
- •Male participants are eligible to participate if they agree to the following
- •during the study intervention period and for at least 3 months after the
- •last administration of study intervention:
- •- Refrain from donating sperm PLUS, either:
- •- Be abstinent from heterosexual intercourse as their preferred and
- •usual lifestyle (abstinent on a long term and persistent basis) and
- •agree to remain abstinent OR;
- •- Must agree to use contraception/barrier method (condom); the
- •participant should also be advised of the benefit for a female partner
- •to use a highly effective method of contraception.
- •b. Female participants:
- •A female participant is eligible to participate if she is not pregnant or
- •breastfeeding, and one of the following conditions applies:
- •- Is a woman of nonchildbearing potential (WONCBP) such as a woman
- •in postmenopausal state (has experienced no menses for 12
- •consecutive months without an alternative medical cause); OR
- •- Has a documented permanent sterilization method such as:
- •o Documented hysterectomy
- •o Documented bilateral salpingectomy
- •o Documented bilateral oophorectomy, OR
- •Is a woman on childbearing potential (WOCBP) and agrees to use a
- •contraceptive method that is highly effective (with a failure rate of
- •<1% per year), with low user dependency.
- •A WOCBP must have a negative highly sensitive pregnancy test (urine) during
- •screening and prior to each psylocibin administration.
- •Consent for study team to contact participant’s HCP team to notify them
- •of trial participation and for the arrangement of follow-up care in the event
- •of discontinuation from the trial (including discontinuation due to withdrawal
- •of consent from trial participation
排除标准
- •Participants unable to provide written informed consent.
- •Participants with history of current or previously diagnosed psychotic
- •disorder, or bipolar disorder.
- •Immediate family member with a diagnosed psychotic disorder.
- •Participants that are pregnant or breastfeeding. Positive pregnancy test
- •at screening or prior to any psilocybin administration or refusal to have an
- •on-site B-HCG pregnancy test prior to any psilocybin administration.
- •Participants who may have sexual contact, without contraceptive
- •measures, with a person who may become pregnant during or within 90 days
- •(or 3 months) of cessation of the psilocybin IMP.
- •Participants with history of serious suicide attempts or with a current
- •Columbia-Suicide Severity Rating Scale (C-SSRS) positive (YES) for questions
- •4,5 or 6, or deliberate self-harm within the last year.
- •Participants with any of Cluster B personality disorder such as:
- •Borderline personality disorder
- •Histrionic personality disorder
- •Antisocial personality disorder
- •Narcissistic personality disorder
- •Participants with eating disorders such as:
- •Anorexia Nervosa
- •Bulimia Nervosa
- •Binge Eating Disorder
- •Other Specified Feeding and Eating Disorder
- •Rumination Disorder
- •Avoidant/Restrictive Food Intake Disorder
- •Unspecified Feeding or Eating Disorder
- •o Muscle Dysmorphia
- •o Orthorexia Nervosa
- •Participants who are receiving any Selective Serotonin recapture Inhibitor
- •(SSRI) during the last 4 weeks. A washout period of 4 weeks (5 weeks for
- •fluoxetine) prior to the enrolment is permitted. Patients who have received an
- •Inhibitor of Mono-amino-oxidase (MAOIs) or patients receiving any other agent
- •that may precipitate a serotonin syndrome (such as, but not limited to: LTryptophan, Selective Serotonin Reuptake Inhibitors, Tricyclic antidepressants,
- •Tramadol, Buspirone, Amphetamines and anorectics, Atypical antidepressants,
- •St John’s wort, or Lithium) in the previous 4 weeks before the study enrollment.
- •Participants with known history of serotonin syndrome, neuroleptic
- •malignant syndrome or malignant hyperthermia.
- •Moderate to severe systolic or diastolic hypertension, or uncontrolled
- •mild hypertension, a previous hypertensive crisis or a known or suspected
- •aneurysm or history of intracerebral haemorrhage.
- •Participants with evidence of mild to severe moderate hepatic
- •impairment (Child Pughclass A-C)
- •Participants with evidence of mild to severe renal impairment
- •(GFR <70mL/min)
- •Hypersensitivity to any of the study interventions, including any
- •constituents thereof, or drug or other allergy that, in the opinion of the
- •Investigator, contraindicates participation in the study.
- •Clinically significant abnormal ECG at screening/baseline or during the
- •dosing period that may, in the judgement of the investigator, affect the
- •conduct of the study.
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