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NCT Number: NCT06651112

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).

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Key information

Conditions

First Episose Psychosis Acid-Base Imbalance Acidosis Ketosis Mental Disorders Metabolic Disease Metabolic Diseases Nutritional and Metabolic Diseases Psychosis; Episode Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hotel-Dieu CIUSSS de l'Estrie-CHUS

Sherbrooke, Quebec, J1H 4C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antipsychotic drugs

Drug

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

Primary outcomes

  1. 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

  2. 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

  1. % 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)

  2. Concentration of glucose

    Time frame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks

    Concentration of glucose measure in fasting plasma

  3. Concentration of insuline

    Time frame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks

    Concentration of insulinemeasure in fasting plasma

  4. Concentration of Hemoglobin A1C

    Time frame: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks

    Concentration of HbA1C measured in fasting plasma

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Melanie Fortier, M.Sc

CONTACT

[email protected]

8195758134

Stephen Cunnane, Ph.D.

CONTACT

[email protected]

819-780-2220 ext. 45670

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Baszucki Brain Research Fund

Registry information

Official study title

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

Acronym: ATP

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 21, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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