The ATP Project (Antipsychotic-TEP-Psychosis) (ATP)

November 6, 2024 updated by: Stephen Cunnane, Université de Sherbrooke

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 4C4
        • Hotel-Dieu CIUSSS de l'Estrie-CHUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Antipsychotic drugs
Any Antipsychotic drugs prescripbe as standrd of care for this specific populaton

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Net inflow of glucose and acetoacetate (k) as measured by PET scan with 18F-FDG and 11C-AcAc traceur (Kglu and Kacac, min-1)
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of change in Brief Psychiatric Rating Scale
Time Frame: 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)
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Concentration of glucose
Time Frame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Concentration of glucose measure in fasting plasma
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Concentration of insuline
Time Frame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Concentration of insulinemeasure in fasting plasma
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Concentration of Hemoglobin A1C
Time Frame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Concentration of HbA1C measured in fasting plasma
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global brain volume measured by MRI
Time Frame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Global brain volumes measured as global brain volumes (ml) measured by MRI
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Thicknesses of the cerebral cortex
Time Frame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Thicknesses of the cerebral cortex (mm) measured by MRI
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Depression status measured by the score of "Calgary Depression Scale for Schizophrenia
Time Frame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Score of "Calgary Depression Scale for Schizophrenia" (CDSS) . Min score 0, maximum score 27 with worsening of the patient condition with hight value
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Functionning level measured by the score of the Global Assessment of functionning
Time Frame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Score of the "Global Assessment of functionning (GAF). Min score 0, maximum score 100, with worsening of the patient condition with higher value
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Side effet score measured by the Side Effect Rating Scale
Time Frame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Score on the "Side Effect Rating Scale" UKU. Min score 0, maximum score 135 (female) 129 (male), with worsening of the side effect with higher value
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Alcohol consumption measured by the score of the Alcohol Use Disorders Identification Test -AUDIT
Time Frame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks

Alcoohol consumption as measured by the score of the Alcohol Use Disorders Identification Test AUDIT.

Min score 0, maximum score 40, with higher alcool consumption with higher value of the score
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Drug consumption measured by the score of the Drug Use Disorders Identification Test -DUDIT
Time Frame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks

Drug consumption as measured by the score of the Drug Use Disorders Identification Test DUDIT.

Min score 0, maximum score 40, with higher alcool consumption with higher value of the score
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Average weekly hours of sport/exercise per day
Time Frame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Average weekly hours of sport/exercise per day" as measured by question 4 of the Simple Physical Activity questionnaire SIMPAQ (hour)
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

Baszucki Brain Research Fund

Investigators

  • Principal Investigator: Stephen Cunnane, Ph.D, Université de Sherbrooke
  • Principal Investigator: Kevin Zemmour, MD, Université de Sherbrooke
  • Principal Investigator: Maggie Hahn, MD, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

October 11, 2024

First Submitted That Met QC Criteria

October 18, 2024

First Posted (Actual)

October 21, 2024

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 6, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-5589

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metabolic Disease

Clinical Trials on Antipsychotic drugs

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe