An interventional study of Cerebral MRI with Phosphorus 31 Magnetic Resonance Spectroscopy in Patients With Ultra High Risk of Psychotic Transition, sponsored by Centre Hospitalier Henri Laborit. Recruiting at 1 site in France. Open to participants aged 15 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Centre Hospitalier Henri Laborit · Not applicable, Interventional, and Diagnostic
The management of schizophrenia is a major public health issue, due to its particularly disabling psychotic symptoms and their onset at an early age, typically in adolescents or young adults.
The physiopathological hypothesis of an anomaly relating to the renewal of cell membranes and energy metabolism in schizophrenia was proposed as early as the 1930s. This is based on anomalies at certain times in the development of the balance between phosphomonesters, precursors of membrane phospholipids, and phosphodiesters, catabolites of membrane phospholipids. Alterations of these different balances sign neurodevelopmental disorders, and can be objectified by specific techniques such as phosphorus-31 magnetic resonance spectroscopy (SMR-31P). This is used in particular to characterize the energy metabolism of the brain and allows in vivo quantification of phosphorus metabolites.
The application of SMR-31P techniques to assess the metabolism of membrane phospholipids and cellular energy metabolism in subjects at high risk of psychotic transition could make it possible to objectify a difference between subjects subsequently suffering from a psychotic transition compared to those who do not suffer from it. Alterations in the metabolism of membrane phospholipids could thus represent a biomarker of psychotic transition. Secondarily, this approach would make it possible to provide elements as to the validity as a diagnosis of this category, which is very heterogeneous in its future.
Among the Ultra High Risk (UHR) group, subjects with a psychotic transition (UHR-T) are compared to subjects without this transition (UHR-NT) during the two years of follow-up.
The UHR group is compared to the control group.
At T0, UHR patients and healthy volunteers will perform brain MRI with Phosphorus 31 magnetic resonance spectroscopy.
UHR patients will then be reviewed:
Centre Hospitalier Henri Laborit is the lead sponsor of 27 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for the UHR group:
Inclusion Criteria for the Control group:
Exclusion Criteria for the UHR group:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants of this group are subjects with ultra high risk of psychotic transition. At inclusion visit, subjects will have a psychiatric evaluation and a cerebral MRI examination with phosphorus 31 Magnetic Resonance Spectroscopy in order to investigate membrane phospholipid metabolism and cellular energy metabolism. One and two years after the inclusion visit, subjects will have a psychiatric evaluation in order to objectivize if a psychotic transition has occured.
Diagnostic Test: Cerebral MRI with Phosphorus 31 Magnetic Resonance Spectroscopy
Participants of this group are healthy volunteers. Subjects will have one single visit with a psychiatric evaluation and a cerebral MRI examination with phosphorus 31 Magnetic Resonance Spectroscopy in order to investigate membrane phospholipid metabolism and cellular energy metabolism.
Diagnostic Test: Cerebral MRI with Phosphorus 31 Magnetic Resonance Spectroscopy
Cerebral MRI with Phosphorus 31 Magnetic Resonance Spectroscopy
Difference of cellular inorganic phosphate between UHR-T and UHR-NT patients.
Levels measurements of inorganic phosphate.
Time frame: 2 years
Difference of cellular phosphocreatine between UHR-T and UHR-NT patients.
Levels measurements of phosphocreatine.
Time frame: 2 years
Difference of cellular Gamma ATP between UHR-T and UHR-NT patients.
Levels measurements of Gamma ATP.
Time frame: 2 years
Difference of cellular Alpha ATP between UHR-T and UHR-NT patients.
Levels measurements of Alpha ATP.
Time frame: 2 years
Difference of cellular beta ATP between UHR-T and UHR-NT patients.
Levels measurements of beta ATP.
Time frame: 2 years
Difference of intracellular pH between UHR-T and UHR-NT patients.
Levels measurements of intracellular pH.
Time frame: 2 years
Difference of membrane phosphodiester alterations between UHR-T and UHR-NT patients.
Levels measurements of phosphodiester.
Time frame: 2 years
Difference of membrane phosphomonoester alterations between UHR-T and UHR-NT patients.
Levels measurements of phosphomonoester.
Time frame: 2 years
Difference of cellular inorganic phosphate between UHR subjects and control subjects.
Levels measurements of inorganic phosphate.
Time frame: 2 years
Difference of cellular phosphocreatine between UHR subjects and control subjects.
Levels measurements of phosphocreatine.
Time frame: 2 years
Difference of cellular Gamma ATP between UHR subjects and control subjects.
Levels measurements of Gamma ATP.
Time frame: 2 years
Difference of cellular Alpha ATP between UHR subjects and control subjects.
Levels measurements of Alpha ATP.
Time frame: 2 years
Difference of cellular beta ATP between UHR subjects and control subjects.
Levels measurements of beta ATP.
Time frame: 2 years
Difference of cellular intracellular pH between UHR subjects and control subjects.
Levels measurements of intracellular pH.
Time frame: 2 years
Difference of membrane phosphodiester alterations between UHR subjects and control subjects.
Levels measurements of phosphodiester.
Time frame: 2 years
Difference of membrane phosphomonoester alterations between UHR subjects and control subjects.
Levels measurements of phosphomonoester.
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Centre Hospitalier Henri Laborit