First Episose PsychosisATPNCT06651112
The ATP Project (Antipsychotic-TEP-Psychosis)
An observational study of First Episose Psychosis and Metabolic Disease, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- First Episose Psychosis, Metabolic Disease, Psychosis; Episode
- What is being tested?
- Antipsychotic drugs
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2024to 1 Jun 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impacts of Psychosis and Antipsychotics on Cerebral Energy Metabolism: the ATP Project (Antipsychotic-TEP-Psychosis)
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).
- Being tested
- Antipsychotic drugs
- Keywords
- psychosis, cerebral metabolism, glucose, ketone, PET scan
- Medical subject headings
- Metabolic Diseases, Psychotic Disorders, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antipsychotic drugsDrug
Any Antipsychotic drugs prescripbe as standrd of care for this specific populaton
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Antipsychotic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Secondary outcomes (4)
% of change in Brief Psychiatric Rating Scale
% of change in the Brief psychiatric Rating Scale (raw score after/raw score before*100)
Measured: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Concentration of glucose
Concentration of glucose measure in fasting plasma
Measured: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Concentration of insuline
Concentration of insulinemeasure in fasting plasma
Measured: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Concentration of Hemoglobin A1C
Concentration of HbA1C measured in fasting plasma
Measured: BEFORE introduction of antipsychotic medicationand AFTER 4 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for First Episose PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Baszucki Brain Research Fund
- Responsible party
- Principal investigator, Stephen Cunnane, Université de Sherbrooke
- Investigators
- Stephen Cunnane, Ph.D, Principal investigator, Université de SherbrookeKevin Zemmour, MD, Principal investigator, Université de SherbrookeMaggie Hahn, MD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651112
- Sponsor's protocol ID
- 2025-5589
- Acronym
- ATP
- Status last verified
- Nov 2024
- First submitted
- 11 Oct 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32709961Croteau 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.
PubMed 29914035Croteau 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.
PubMed 28709938Agarwal 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.
PubMed 31152767Fortier 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.
PubMed 33103819Andreasen 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.
PubMed 9193383Townsend 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.
PubMed 35730361Henkel 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.
PubMed 35264726Lee 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.
PubMed 38199991Agarwal 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.
PubMed 36190739Raben 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.
PubMed 29403343Vancampfort 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.
PubMed 26407790Sabe 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.
PubMed 36752753Fan 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.
PubMed 23953755Correll 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.
PubMed 37326421