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The ATP Project (Antipsychotic-TEP-Psychosis)

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06651112
Acronym
ATP
Enrollment
18
Registered
2024-10-21
Start date
2024-11-01
Completion date
2027-06-01
Last updated
2024-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First Episose Psychosis, Metabolic Disease, Psychosis; Episode

Keywords

psychosis, cerebral metabolism, glucose, ketone, PET scan

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).

Interventions

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

Sponsors

Baszucki Brain Research Fund
CollaboratorOTHER
Université de Sherbrooke
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cerebral metabolic rate of glucose and acetotacetateBEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeksCerebral 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 acetoacetateBEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeksNet inflow of glucose and acetoacetate (k) as measured by PET scan with 18F-FDG and 11C-AcAc traceur (Kglu and Kacac, min-1)

Secondary

MeasureTime frameDescription
% of change in Brief Psychiatric Rating ScaleBEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks% of change in the Brief psychiatric Rating Scale (raw score after/raw score before\*100)
Concentration of glucoseBEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeksConcentration of glucose measure in fasting plasma
Concentration of insulineBEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeksConcentration of insulinemeasure in fasting plasma
Concentration of Hemoglobin A1CBEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeksConcentration of HbA1C measured in fasting plasma

Other

MeasureTime frameDescription
Drug consumption measured by the score of the Drug Use Disorders Identification Test -DUDITBEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeksDrug 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
Global brain volume measured by MRIBEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeksGlobal brain volumes measured as global brain volumes (ml) measured by MRI
Average weekly hours of sport/exercise per dayBEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeksAverage weekly hours of sport/exercise per day as measured by question 4 of the Simple Physical Activity questionnaire SIMPAQ (hour)
Thicknesses of the cerebral cortexBEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeksThicknesses of the cerebral cortex (mm) measured by MRI
Depression status measured by the score of Calgary Depression Scale for SchizophreniaBEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeksScore of Calgary Depression Scale for Schizophrenia (CDSS) . Min score 0, maximum score 27 with worsening of the patient condition with hight value
Functionning level measured by the score of the Global Assessment of functionningBEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeksScore of the Global Assessment of functionning (GAF). Min score 0, maximum score 100, with worsening of the patient condition with higher value
Side effet score measured by the Side Effect Rating ScaleBEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeksScore 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
Alcohol consumption measured by the score of the Alcohol Use Disorders Identification Test -AUDITBEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeksAlcoohol 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

Countries

Canada

Contacts

Primary ContactMelanie Fortier, M.Sc
melanie.fortier2@usherbrooke.ca8195758134
Backup ContactStephen Cunnane, Ph.D.
melanie.fortier2@usherbrooke.ca819-780-2220

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026