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临床试验/NCT03069612
NCT03069612终止不适用

Evaluating Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Cannabis Dependence and Working Memory in Patients With Early Psychosis

Centre for Addiction and Mental Health2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
2
主要终点
Cannabis Abstinence

研究概览

简要总结

Cannabis use during adolescence represents a significant risk factor for the development of psychosis including schizophrenia. Moreover, cannabis is the most commonly used drug among patients with an existing psychotic disorder. An estimated 25% of patients with psychosis reportedly meet the criteria of a cannabis use disorder particularly among younger patients experiencing their first episode. Cannabis use significantly exacerbates symptomatology resulting in an increased duration of the first hospitalization visit, number of hospital readmissions, and overall reduced functional outcome. Discovering novel strategies to treat the underlying pathophysiology of cannabis dependence early in the disorder may translate into improved functional outcome. Working memory deficits have been shown to predict relapse in the first-year of psychosis and is modulated with cannabis use. Repetitive transcranial magnetic stimulation (rTMS) targeted to the dorsolateral prefrontal cortex (DLPFC) has shown tremendous promise for the treatment of both tobacco dependence and working memory impairment in patients with psychosis possibly through the modulation of gamma (30-50 Hz) oscillations. The proposed study will therefore evaluate the effect of rTMS on abstinence, working memory performance, and gamma oscillations through a randomized, double-blind, placebo-controlled 28-day longitudinal abstinence study design in patients with early psychosis. It will further explore if baseline performance and gamma oscillations predict abstinence in response to rTMS. It is hypothesized that active compared to sham rTMS will improve abstinence rates and improve working memory performance through the modulation of gamma oscillations.

详细描述

This a randomized, double-blind placebo-controlled, longitudinal 28-Day abstinence study design. Patients with psychosis will be randomized (1:1) to receive either active or sham stimulation that will be administered three times per week for 4 weeks (28 days) for a total of 12 treatments. Urine will be collected three times per week prior to the rTMS treatment. Cognition including the N-Back task and MATRICS cognitive battery will be administered on Day 0, Day 28, and Day 42 to determine the effect of rTMS on cognition compared to sham stimulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
16 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 16-35
  • Meet Diagnostic and Statistical Manual for Mental Disorders (DSM)-5 diagnostic criteria for a cannabis use disorder with physiological evidence of dependence; plus one of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar I disorder, major depressive disorder with psychotic features, cannabis-induced psychosis, or psychosis not otherwise specified
  • Full scale IQ ≥ 80 determined through the Wechler Test for Adult Reading (WTAR)
  • Daily cigarette smoker of ≥ 5 cigarettes per day

排除标准

  • DSM-5 diagnoses of alcohol, substance or poly-use substance use disorder in the past 6 months (other than cannabis/caffeine or nicotine)
  • Currently active suicidal ideation or self-harm (suicidal or non-suicidal)
  • Head injury resulting in loss of consciousness and hospitalization
  • Major neurological or medical illness including seizure disorder or syncope
  • Metallic implants
  • History of rTMS treatment
  • Pregnancy

研究组 & 干预措施

rTMS Active Group

Experimental

Repetitive transcranial magnetic stimulation (rTMS) will be administered bilaterally to the dorsolateral prefrontal cortex (DLPFC) at 20 Hz, 90% RMT in 25 trains.

干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)

rTMS Sham Group

Sham Comparator

Repetitive transcranial magnetic stimulation (rTMS) will be administered bilaterally to the dorsolateral prefrontal cortex (DLPFC) at 20 Hz, 90% RMT in 25 trains with a sham coil.

干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)

结局指标

主要结局

Cannabis Abstinence

时间窗: Change of COOH and creatinine concentrations.from baseline to Day 28.

Gas chromatography/mass spectrometry (GC/MS) analysis to obtain quantitative THC-COOH and creatinine concentrations.

次要结局

  • Working Memory Performance(Baseline, trial endpoint (Day 28) and at follow up (Day 56) for a total of 3 times.)
  • Gamma Oscillations(Baseline, trial endpoint (Day 28) and at follow up (Day 56) for a total of 3 times.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mera Barr

Independent Scientist

Centre for Addiction and Mental Health

研究点 (2)

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