NCT05581797已完成不适用
Psilocybin-assisted Interpersonal Therapy for Depression
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The feasibility of recruiting patients with major depression for this treatment in New Zealand
研究概览
简要总结
This is a single-arm, open-label interventional study of psilocybin-assisted interpersonal therapy for treatment resistant depression. 20 participants will be recruited to take part in this 8-week intervention that involves 8 sessions of psychotherapy and 2 doses of psilocybin.
详细描述
Study Design Interventional, Single arm, open label
1. Hypotheses:
- It is feasible to deliver Psilocybin treatment integrated into interpersonal therapy for people with treatment resistant major depression (TRD).
- It is feasible to recruit patients with TRD for this treatment in New Zealand.
2. Participants The study will recruit 20 participants who have a current diagnosis of Treatment resistant Major Depressive Disorder. The participants will need to agree to cease psychotropic medications including antidepressants as part of the preparation for psilocybin dosing.
3. Recruitment Participants will be recruited by referral from mental health services, primary care and community advertisements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to give written informed consent
- •Have a confirmed DSM-5 diagnosis of Major Depressive Disorder and currently experiencing a major depressive episode and no improvement despite two adequate courses of antidepressant treatment of different pharmacological classes lasting at least 6 weeks within the current depressive episode
- •Have a baseline total score of >13 on HAMD17 .
- •Agree to discontinue any recommended psychoactive medications, including antidepressants and lithium as part of the study.
- •Agree to refrain from using alcohol and other substances including nicotine, within 24 hours of each drug administration.
- •Be judged by study team clinicians to be at low risk for suicidality
- •Be medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
- •Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days.
- •Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.
- •Agree that for one week before each drug session, he/she will refrain from taking any non-prescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
- •If female, they must agree to pregnancy testing and regular contraception while in study.
- •Have limited lifetime use of hallucinogens (the following criteria are preferred: no use in the past 5 years; total hallucinogen use less than 10 times)
- •Agree to participate in a 10-week combined psychotherapy and psilocybin intervention, complete required measurements (including follow-up measures at week 18) and adhere to safety protocols.
排除标准
- •Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing an effective means of birth control.
- •Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged QTc interval (i.e., QTc > 450 msec), artificial heart valve, or TIA in the past year
- •Epilepsy with history of seizures
- •Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
- •Currently taking psychoactive prescription medication on a regular (e.g., daily) basis which are unable to be ceased (under supervision) during the study period.
- •Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting serotonergic effect, including MAOIs. For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.
- •Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder
- •Current or history within one year of meeting DSM-5 criteria for a moderate or severe alcohol or other drug use disorder (excluding caffeine)
- •Have a first or second-degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder
- •Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin
- •History of a medically significant suicide attempt
- •Has failed to respond to electroconvulsive therapy during the current major depressive episode 13Not fluent in English
研究组 & 干预措施
Psilocybin-assisted psychotherapy
Experimental
Interpersonal Therapy integrated with psilocybin
干预措施: Psilocybin-assisted psychotherapy (Other)
结局指标
主要结局
The feasibility of recruiting patients with major depression for this treatment in New Zealand
时间窗: Week 0
1. The percentage of potential participants who meet the major inclusion/exclusion criteria during phone screening. 2. The percentage of potential participants who enter the study after the in-person screening (see page 2 for description of two-step screening process).
The feasibility of delivery of Psilocybin integrated into Interpersonal Therapy for people with TRD
时间窗: Week 10
Retention rate (participants who complete the full number of treatment sessions).
次要结局
- Qualitative interview(Week 18)
- Therapy Goals Measurement (TGM)(This will be completed at week 2, 9 and 18.)
- GRID-Hamilton Depression Rating Scale (GRID-HAMD)(Completed at baseline, week 1,2,3,4,5,6,7,8,9,18)
- Social Adjustment Scale - Modified (SAS-M)(This will be completed at baseline, prior to first dosing, weeks 9 and 18.)
- Antidepressant Discontinuation Symptom Measurement (ADSM)(This will be completed at week 1,2, and 3.)
- Revised Mystical Experiences Questionnaire (MEQ30)(At the end of psilocybin dosing session in Week 4 and Week 5)
- Aotearoa Adapted Watts Connectedness Scale (AA-WCS).(At the end of psilocybin dosing session in Week 4 and Week 5)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Neurobiological Effects of Psilocybin in Treatment Resistant Bipolar DepressionBipolar DepressionNCT06506019University Health Network, Toronto30
已完成
1 期
Interpersonal Psychotherapy for Depressed Adolescents Engaging in Non-suicidal Self-injurySelf-injurious BehaviorDepressionNCT00401102New York State Psychiatric Institute10
进行中（未招募）
2 期
Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)Alcohol Use DisorderNCT05646303Clairvoyant Therapeutics128
招募中
1 期
Psilocybin for hospitalized patients with treatment-resistant depressiotreatment-resistant depressionCTIS2022-501857-35-00niversitair Ziekenhuis Gent100
已完成
不适用
Internet-administered Interpersonal Psychotherapy for Depressive SymptomsMajor Depressive DisorderNCT04721678Linkoeping University113