The ATP Project (Antipsychotic-TEP-Psychosis)

Официальное название

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

Обзор

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).

Вмешательства

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

Первичные конечные точки

• Cerebral metabolic rate of glucose and acetotacetate [Срок оценки: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks]
• Net inflow of glucose and acetoacetate [Срок оценки: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks]

Вторичные конечные точки (4)

• % of change in Brief Psychiatric Rating Scale [Срок оценки: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks]
• Concentration of glucose [Срок оценки: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks]
• Concentration of insuline [Срок оценки: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks]
• Concentration of Hemoglobin A1C [Срок оценки: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 1 центр

• Hotel-Dieu CIUSSS de l'Estrie-CHUS — Sherbrooke

Публикации

• 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 agein PMID 32709961
• 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. PMID 29914035
• 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. PMID 28709938
• Agarwal SM, Kowalchuk C, Castellani L, Costa-Dookhan KA, Caravaggio F, Asgariroozbehani R, Chintoh A, Graff-Guerrero A, Hahn M. Brain insulin action: Implications for the treatment of schizophrenia. Neuropharmacology. 2020 May 15;168:107655. doi: 10.1016/j.neuropharm.2019.05.032. Epub 2019 May 29. PMID 31152767
• 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. PMID 33103819
• 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. PMID 9193383
• Townsend L, Pillinger T, Selvaggi P, Veronese M, Turkheimer F, Howes O. Brain glucose metabolism in schizophrenia: a systematic review and meta-analysis of 18FDG-PET studies in schizophrenia. Psychol Med. 2023 Aug;53(11):4880-4897. doi: 10.1017/S003329172200174X. Epub 2022 Jun 22. PMID 35730361
• 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. PMID 35264726

Идентификаторы

NCT: NCT06651112 · 2025-5589

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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