The ATP Project (Antipsychotic-TEP-Psychosis)

NCT ID: NCT06651112

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2027-06-01

Brief Summary

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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).

Detailed Description

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Conditions

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First Episose Psychosis Metabolic Disease Psychosis; Episode

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Antipsychotic drugs

Intervention Type DRUG

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

Interventions

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Antipsychotic drugs

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baszucki Brain Research Fund

OTHER

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Stephen Cunnane

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen Cunnane, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Kevin Zemmour, MD

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Maggie Hahn, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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Hotel-Dieu CIUSSS de l'Estrie-CHUS

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Central Contacts

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Melanie Fortier, M.Sc

Role: CONTACT

8195758134

Stephen Cunnane, Ph.D.

Role: CONTACT

819-780-2220 ext. 45670

References

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Cunnane SC, Trushina E, Morland C, Prigione A, Casadesus G, Andrews ZB, Beal MF, Bergersen LH, Brinton RD, de la Monte S, Eckert A, Harvey J, Jeggo R, Jhamandas JH, Kann O, la Cour CM, Martin WF, Mithieux G, Moreira PI, Murphy MP, Nave KA, Nuriel T, Oliet SHR, Saudou F, Mattson MP, Swerdlow RH, Millan MJ. Brain energy rescue: an emerging therapeutic concept for neurodegenerative disorders of ageing. Nat Rev Drug Discov. 2020 Sep;19(9):609-633. doi: 10.1038/s41573-020-0072-x. Epub 2020 Jul 24.

Reference Type BACKGROUND
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Croteau E, Castellano CA, Richard MA, Fortier M, Nugent S, Lepage M, Duchesne S, Whittingstall K, Turcotte EE, Bocti C, Fulop T, Cunnane SC. Ketogenic Medium Chain Triglycerides Increase Brain Energy Metabolism in Alzheimer's Disease. J Alzheimers Dis. 2018;64(2):551-561. doi: 10.3233/JAD-180202.

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Croteau E, Castellano CA, Fortier M, Bocti C, Fulop T, Paquet N, Cunnane SC. A cross-sectional comparison of brain glucose and ketone metabolism in cognitively healthy older adults, mild cognitive impairment and early Alzheimer's disease. Exp Gerontol. 2018 Jul 1;107:18-26. doi: 10.1016/j.exger.2017.07.004. Epub 2017 Jul 12.

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Fortier M, Castellano CA, St-Pierre V, Myette-Cote E, Langlois F, Roy M, Morin MC, Bocti C, Fulop T, Godin JP, Delannoy C, Cuenoud B, Cunnane SC. A ketogenic drink improves cognition in mild cognitive impairment: Results of a 6-month RCT. Alzheimers Dement. 2021 Mar;17(3):543-552. doi: 10.1002/alz.12206. Epub 2020 Oct 26.

Reference Type BACKGROUND
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Andreasen NC, O'Leary DS, Flaum M, Nopoulos P, Watkins GL, Boles Ponto LL, Hichwa RD. Hypofrontality in schizophrenia: distributed dysfunctional circuits in neuroleptic-naive patients. Lancet. 1997 Jun 14;349(9067):1730-4. doi: 10.1016/s0140-6736(96)08258-x.

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Henkel ND, Wu X, O'Donovan SM, Devine EA, Jiron JM, Rowland LM, Sarnyai Z, Ramsey AJ, Wen Z, Hahn MK, McCullumsmith RE. Schizophrenia: a disorder of broken brain bioenergetics. Mol Psychiatry. 2022 May;27(5):2393-2404. doi: 10.1038/s41380-022-01494-x. Epub 2022 Mar 9.

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Lee J, Xue X, Au E, McIntyre WB, Asgariroozbehani R, Panganiban K, Tseng GC, Papoulias M, Smith E, Monteiro J, Shah D, Maksyutynska K, Cavalier S, Radoncic E, Prasad F, Agarwal SM, Mccullumsmith R, Freyberg Z, Logan RW, Hahn MK. Glucose dysregulation in antipsychotic-naive first-episode psychosis: in silico exploration of gene expression signatures. Transl Psychiatry. 2024 Jan 10;14(1):19. doi: 10.1038/s41398-023-02716-8.

Reference Type BACKGROUND
PMID: 38199991 (View on PubMed)

Agarwal SM, Stogios N, Ahsan ZA, Lockwood JT, Duncan MJ, Takeuchi H, Cohn T, Taylor VH, Remington G, Faulkner GEJ, Hahn M. Pharmacological interventions for prevention of weight gain in people with schizophrenia. Cochrane Database Syst Rev. 2022 Oct 3;10(10):CD013337. doi: 10.1002/14651858.CD013337.pub2.

Reference Type BACKGROUND
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Vancampfort D, Stubbs B, Mitchell AJ, De Hert M, Wampers M, Ward PB, Rosenbaum S, Correll CU. Risk of metabolic syndrome and its components in people with schizophrenia and related psychotic disorders, bipolar disorder and major depressive disorder: a systematic review and meta-analysis. World Psychiatry. 2015 Oct;14(3):339-47. doi: 10.1002/wps.20252.

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Sabe M, Pallis K, Solmi M, Crippa A, Sentissi O, Kaiser S. Comparative Effects of 11 Antipsychotics on Weight Gain and Metabolic Function in Patients With Acute Schizophrenia: A Dose-Response Meta-Analysis. J Clin Psychiatry. 2023 Feb 8;84(2):22r14490. doi: 10.4088/JCP.22r14490.

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Reference Type BACKGROUND
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Correll CU, Hojlund M, Graham C, Todtenkopf MS, McDonnell D, Simmons A. Weight Gain and Metabolic Changes in Patients With First-Episode Psychosis or Early-Phase Schizophrenia Treated With Olanzapine: A Meta-Analysis. Int J Neuropsychopharmacol. 2023 Jul 31;26(7):451-464. doi: 10.1093/ijnp/pyad029.

Reference Type BACKGROUND
PMID: 37326421 (View on PubMed)

Other Identifiers

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2025-5589

Identifier Type: -

Identifier Source: org_study_id

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