Evaluating brain metabolism in young people at high risk for psychosis
Evaluation of Membrane Phospholipid Metabolism and Cellular Energy Metabolism in Subjects at High Risk of Psychotic Transition
This study is trying to see how brain metabolism works in young people aged 15 to 25 who are at high risk for developing psychosis, compared to healthy individuals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 15 Years to 25 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Henri Laborit Academic / other |
| Locations | 1 site (Poitiers) |
| Trial ID | NCT05865652 on ClinicalTrials.gov |
What this trial studies
This study investigates the metabolic processes in the brains of individuals aged 15 to 25 who are at ultra high risk for psychotic transition. Using advanced phosphorus-31 magnetic resonance spectroscopy (SMR-31P), the research aims to assess the balance of membrane phospholipids and energy metabolism in these patients. Participants will undergo cerebral MRI scans to quantify phosphorus metabolites, which may provide insights into neurodevelopmental disorders associated with schizophrenia. The study includes both high-risk patients and healthy controls for comparative analysis.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 15 to 25 who meet the criteria for ultra high risk of psychotic transition.
Not a fit: Patients outside the age range of 15 to 25 or those with established mental health disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and early intervention strategies for individuals at risk of developing schizophrenia.
How similar studies have performed: While the specific application of SMR-31P in this context may be novel, similar studies have shown promise in understanding metabolic changes in psychotic disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for the UHR group: * Patient between 15 and 25 years old * Patient fulfilling the UHR criteria objectified by the Comprehensive Assessment of At Risk Mental State scale (CAARMS) and by the social and professional functioning assessment scale (SOFAS) (the "Vulnerability" group is also taken into account, combining first-degree history and functional impact.) * Patient with no contraindication to performing a 7T MRI examination * Affiliated patient or beneficiary of a social security scheme. * Free, informed consent, written and signed by the participant, the investigator and the legal representative if applicable (at the latest on the day of inclusion and before any examination required by the research). Inclusion Criteria for the Control group: * Subjects aged 15 to 25 years old, * healthy volunteer subject or subject to benefit from an imaging examination, not presenting the criteria of a mental health disorder objectified by a medical interview * Subject with no contraindication to performing a 7T MRI examination * Affiliated subject or beneficiary of a social security scheme. * Free, informed and written consent signed by the participant, the investigator and the legal representative if applicable (at the latest on the day of inclusion and before any examination required by the research). Exclusion Criteria for the UHR group: * Patient not at risk or already in a psychotic pathological process according to DSM-5 criteria. * Patient already receiving antipsychotic treatment or whose background treatment was changed less than a month ago. * Patient presenting an absolute contraindication to 7T MRI such as: foreign bodies (intracranial clips, vascular magnetic clips, cardiac or neural pacemakers, stents, coils, implantable chamber, intracorporeal metallic splinters, cochlear implants, intracorporeal metallic foreign bodies, mechanical heart valve, implanted injection pump, non-removable piercings), pregnant woman, allergy to contrast products, moderate to severe renal insufficiency, breastfeeding, implanted contraception, tinnitus, claustrophobia and braces. The relative contraindications are to be considered, namely: previous surgical interventions, medically implanted device, tattoo or permanent make-up. Exclusion criteria for the control group: \- Subject presenting an absolute contraindication to 7T MRI such as: foreign bodies (intracranial clips, vascular magnetic clips, cardiac or neural pacemakers, stents, coils, implantable chamber, intracorporeal metallic fragments, cochlear implants, intracorporeal metallic foreign bodies, valve mechanical heart, implanted injection pump, non-removable piercings), pregnant woman, allergy to contrast products, moderate to severe renal insufficiency, breast-feeding, implanted contraception, tinnitus, claustrophobia and braces. The relative contraindications are to be considered, namely: previous surgical interventions, medically implanted device, tattoo or permanent make-up.
Where this trial is running
Poitiers
- Centre Hospitalier Henri Laborit — Poitiers, France (Recruiting)
Study contacts
- Study coordinator: Richard HARY
- Email: richard.hary@ch-poitiers.fr
- Phone: 0033 5 49 44 57 57
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.