The ATP Project (Antipsychotic-TEP-Psychosis)
- Conditions
- First Episose PsychosisMetabolic DiseasePsychosis; Episode
- Interventions
- Drug: Antipsychotic drugs
- Registration Number
- NCT06651112
- Lead Sponsor
- Université de Sherbrooke
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 18
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description First episode psychosis Antipsychotic drugs 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.
- Primary Outcome Measures
Name Time Method Cerebral metabolic rate of glucose and acetotacetate 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 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)
- Secondary Outcome Measures
Name Time Method % of change in Brief Psychiatric Rating Scale BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks % of change in the Brief psychiatric Rating Scale (raw score after/raw score before\*100)
Concentration of glucose BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks Concentration of glucose measure in fasting plasma
Concentration of insuline BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks Concentration of insulinemeasure in fasting plasma
Concentration of Hemoglobin A1C BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks Concentration of HbA1C measured in fasting plasma
Trial Locations
- Locations (1)
Hotel-Dieu CIUSSS de l'Estrie-CHUS
🇨🇦Sherbrooke, Quebec, Canada