NCT06651112 The ATP Project (Antipsychotic-TEP-Psychosis)
| NCT ID | NCT06651112 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Université de Sherbrooke |
| Condition | First Episose Psychosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 18 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 18 participants in total. It began in 2024-11-01 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Stephen Cunnane, Ph.D
PRINCIPAL INVESTIGATOR
Université de Sherbrooke
Frequently Asked Questions
Who can join the NCT06651112 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 35 Years, studying First Episose Psychosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06651112 currently recruiting?
Yes, NCT06651112 is actively recruiting participants. Contact the research team at melanie.fortier2@usherbrooke.ca for enrollment information.
Where is the NCT06651112 trial being conducted?
This trial is being conducted at Sherbrooke, Canada.
Who is sponsoring the NCT06651112 clinical trial?
NCT06651112 is sponsored by Université de Sherbrooke. The principal investigator is Stephen Cunnane, Ph.D at Université de Sherbrooke. The trial plans to enroll 18 participants.