Impacts of Psychosis and Antipsychotics on Cerebral Energy Metabolism: the ATP Project (Antipsychotic-TEP-Psychosis)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Cerebral metabolic rate of glucose and acetotacetate
研究概览
简要总结
The goal of this observational study is to the early impacts of psychosis and antipsychotic medications on brain metabolism in young adults recently diagnosed with a first episode of psychosis.
The main question aims to evaluate the effect of 4 to 6 weeks of antipsychotic medication on brain metabolism measured by PET scan (cerebral uptake of 11C-Acetoacetate + 18 Fluorodeoxyglucose).
Participants will undergo a multimodal imaging protocol with other measures of psychopathology (e.g., cognition, depressive symptoms, etc.) and (metabolic marker, inflammation, etc).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to the PEP clinic in Estrie, either outpatient or inpatient, according to the transdiagnostic PEP model.
- •Willingness to begin taking an AP (regardless of type and dose, or change in type and dose during the study).
- •Ability to read and express themselves in French or English.
- •Capable of understanding and signing consent.
排除标准
- •Pregnancy, childbirth in the last 6 months, or breastfeeding.
- •Presence of a metallic object in the body that is incompatible with MRI.
- •Any use of APs for more than 2 continuous weeks in the past year and/or 6 weeks in a lifetime (except for aripiprazole if taken at less than 2.5 mg/day or quetiapine at less than 50 mg/day, regardless of duration or timing of the prescription).
- •The following comorbidities: psychosis + borderline or intellectual disability, autism spectrum disorder, substance use disorder with decompensation, psychosis induced by a medical condition, or psychosis induced by drug use or withdrawal.
- •Type 1 diabetes.
- •Uncontrolled acute suicidal ideation.
- •Other conditions that could interfere with participation according to the judgment of the qualified physician.
研究组 & 干预措施
First episode psychosis
Individuals aged 18 to 35 from the Estrie region who have been evaluated by the "PEP team" (First episode psychosis intervention Team of the pschiatric department of the CIUSSS de l'Estrie-CHUS) and wish to start an antipsychotic (AP) for the treatment of a first episode of psychosis.
干预措施: Antipsychotic drugs (Drug)
结局指标
主要结局
Cerebral metabolic rate of glucose and acetotacetate
时间窗: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Cerebral metabolic rate of glucose and acetotacetate(μmol/100 g/min) quantified with PET scan with 18F-FDG tracer and 11C-AcAc
Net inflow of glucose and acetoacetate
时间窗: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Net inflow of glucose and acetoacetate (k) as measured by PET scan with 18F-FDG and 11C-AcAc traceur (Kglu and Kacac, min-1)
次要结局
- % of change in Brief Psychiatric Rating Scale(BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks)
- Concentration of glucose(BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks)
- Concentration of insuline(BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks)
- Concentration of Hemoglobin A1C(BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks)
研究者
Stephen Cunnane
Professor
Université de Sherbrooke