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Clinical Trials/NCT06651112
NCT06651112
Not yet recruiting
Not Applicable

Impacts of Psychosis and Antipsychotics on Cerebral Energy Metabolism: the ATP Project (Antipsychotic-TEP-Psychosis)

Université de Sherbrooke1 site in 1 country18 target enrollmentNovember 1, 2024

Overview

Phase
Not Applicable
Intervention
Antipsychotic drugs
Conditions
First Episose Psychosis
Sponsor
Université de Sherbrooke
Enrollment
18
Locations
1
Primary Endpoint
Cerebral metabolic rate of glucose and acetotacetate
Status
Not yet recruiting
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 1, 2024
End Date
June 1, 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephen Cunnane

Professor

Université de Sherbrooke

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Arms & Interventions

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.

Intervention: Antipsychotic drugs

Outcomes

Primary Outcomes

Cerebral metabolic rate of glucose and acetotacetate

Time Frame: 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

Time Frame: 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 Outcomes

  • % 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)

Study Sites (1)

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