Clinical trial NCT06651112: The ATP Project (Antipsychotic-TEP-Psychosis)
Official title: Impacts of Psychosis and Antipsychotics on Cerebral Energy Metabolism: the ATP Project (Antipsychotic-TEP-Psychosis)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: First Episose Psychosis
Metabolic Disease
Psychosis; Episode
Keywords: psychosis
cerebral metabolism
glucose
ketone
PET scan
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Baszucki Brain Research Fund
First posted: 2024-10-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals aged 18 to 35 from the Estrie region who have been evaluated by the PEP team and wish to start an antipsychotic (AP) for the treatment of a first episode of psychosis.

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).


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.

Primary outcomes:
measure: Cerebral metabolic rate of glucose and acetotacetate
timeFrame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
measure: Net inflow of glucose and acetoacetate
timeFrame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Secondary outcomes:
measure: % of change in Brief Psychiatric Rating Scale
timeFrame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
measure: Concentration of glucose
timeFrame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
measure: Concentration of insuline
timeFrame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
measure: Concentration of Hemoglobin A1C
timeFrame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Other outcomes:
measure: Global brain volume measured by MRI
timeFrame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
measure: Thicknesses of the cerebral cortex
timeFrame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
measure: Depression status measured by the score of "Calgary Depression Scale for Schizophrenia
timeFrame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
measure: Functionning level measured by the score of the Global Assessment of functionning
timeFrame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
measure: Side effet score measured by the Side Effect Rating Scale
timeFrame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
measure: Alcohol consumption measured by the score of the Alcohol Use Disorders Identification Test -AUDIT
timeFrame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
measure: Drug consumption measured by the score of the Drug Use Disorders Identification Test -DUDIT
timeFrame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
measure: Average weekly hours of sport/exercise per day
timeFrame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Locations:
city: Sherbrooke
country: Canada
facility: Hotel-Dieu CIUSSS de l'Estrie-CHUS
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Stephen Cunnane, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Sherbrooke
name: Kevin Zemmour, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Maggie Hahn, MD
role: PRINCIPAL_INVESTIGATOR
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