Recruiting

Antipsychotic Medication

Sponsor:

Université de Sherbrooke

Code:

NCT06651112

Conditions

First Episose Psychosis

Metabolic Disease

Psychosis; Episode

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

Interventions

Antipsychotic drugs

Study Details

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).

Conditions

First Episose Psychosis

Metabolic Disease

Psychosis; Episode

Study ID

NCT06651112

Start date

Nov 1, 2024

Status verified date

Oct, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

18 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Antipsychotic drugs

Any Antipsychotic drugs prescripbe as standrd of care for this specific populaton

Primary outcome measure

  • Cerebral metabolic rate of glucose and acetotacetate [ Time Frame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks ]
  • Net inflow of glucose and acetoacetate [ Time Frame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks ]

Central Contacts and Locations

Central contacts

Melanie Fortier, M.Sc

8195758134melanie.fortier2@usherbrooke.ca

Stephen Cunnane, Ph.D.

819-780-2220melanie.fortier2@usherbrooke.ca

Locations

Hotel-Dieu CIUSSS de l'Estrie-CHUS

Recruiting

Sherbrooke, Quebec, Canada, J1H 4C4

Contacts

Melanie Fortier, M.Sc.

8195758134melanie.fortier2@usherbrooke.ca

More Information

Sponsor

Université de Sherbrooke

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Keywords

  • psychosis
  • cerebral metabolism
  • glucose
  • ketone
  • PET scan

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.