NCT06651112|Recruiting
The ATP Project (Antipsychotic-TEP-Psychosis)
ATP
Impacts of Psychosis and Antipsychotics on Cerebral Energy Metabolism: the ATP Project (Antipsychotic-TEP-Psychosis)
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ATP
Impacts of Psychosis and Antipsychotics on Cerebral Energy Metabolism: the ATP Project (Antipsychotic-TEP-Psychosis)
Sponsor study identifier
observational
18
1 country
1
Study Start
November 1, 2024
Actual (reported)Primary Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 11, 2024
Actual (reported)October 21, 2024
Actual (reported)November 1, 2024
Actual (reported)December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Cerebral metabolic rate of glucose and acetotacetate
Cerebral metabolic rate of glucose and acetotacetate(μmol/100 g/min) quantified with PET scan with 18F-FDG tracer and 11C-AcAc
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Net inflow of glucose and acetoacetate
Net inflow of glucose and acetoacetate (k) as measured by PET scan with 18F-FDG and 11C-AcAc traceur (Kglu and Kacac, min-1)
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
% of change in Brief Psychiatric Rating Scale
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
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.
Any Antipsychotic drugs prescripbe as standrd of care for this specific populaton
Individuals aged 18 to 35 from the Estrie region who have been evaluated by the PEP team and wish to start an antipsychotic (AP) for the treatment of a first episode of psychosis.
Hotel-Dieu CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec, J1H 4C4, Canada
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.
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.
Plasma will be collected from whole blood sample.
Stephen Cunnane, Ph.D
Université de Sherbrooke
Kevin Zemmour, MD
Université de Sherbrooke
Maggie Hahn, MD
University of Toronto
First Submitted
October 11, 2024
First Posted
October 21, 2024
Study Start
November 1, 2024
Actual (reported)Primary Completion
December 1, 2027
EstimatedObeservational Cohort for Evaluating Future Cardiovascular Disease With High Metabolic Risks
Concentration of glucose
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Concentration of insuline
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Concentration of Hemoglobin A1C
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Global brain volume measured by MRI
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Thicknesses of the cerebral cortex
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Depression status measured by the score of "Calgary Depression Scale for Schizophrenia
BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
Raben AT, Marshe VS, Chintoh A, Gorbovskaya I, Muller DJ, Hahn MK. The Complex Relationship between Antipsychotic-Induced Weight Gain and Therapeutic Benefits: A Systematic Review and Implications for Treatment. Front Neurosci. 2018 Jan 22;11:741. doi: 10.3389/fnins.2017.00741. eCollection 2017.
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.
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.
Fan Z, Wu Y, Shen J, Ji T, Zhan R. Schizophrenia and the risk of cardiovascular diseases: a meta-analysis of thirteen cohort studies. J Psychiatr Res. 2013 Nov;47(11):1549-56. doi: 10.1016/j.jpsychires.2013.07.011. Epub 2013 Aug 15.
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.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 26, 2026
Record last verified: 2026-10
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