Patients With Ultra High Risk of Psychotic TransitionMR7T-UHRNCT05865652
Evaluation of Membrane Phospholipid and Energy Metabolism in Subjects at High Risk of Psychotic Transition
A study testing Cerebral MRI with Phosphorus 31 Magnetic Resonance Spectroscopy in people with Patients With Ultra High Risk of Psychotic Transition, run by Centre Hospitalier Henri Laborit at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients With Ultra High Risk of Psychotic Transition
- What is being tested?
- Cerebral MRI with Phosphorus 31 Magnetic Resonance Spectroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2023to May 2028
- Phase
- Interventional
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 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
- Subjects aged 15 to 25 years old,
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- 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).
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Henri Laborit
Poitiers, 86000
Richard HARY, 0033 5 49 44 57 57, richard.hary@ch-poitiers.fr
About this study
Official title: Evaluation of Membrane Phospholipid Metabolism and Cellular Energy Metabolism in Subjects at High Risk of Psychotic Transition
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.
Read more
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:
- at T+1 year for a clinical assessment medical interview to assess the patient's functioning and the appearance of symptoms;
- at T+2 years for the realization of a follow-up interview with passing of the scales CAARMS (Comprehensive Assessment of At Risk Mental State) and SOFAS (scale of evaluation of the social and professional functioning) in order to determine if the subject belongs to the UHR-T or UHR-NT group.
- Being tested
- Cerebral MRI with Phosphorus 31 Magnetic Resonance Spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral MRI with Phosphorus 31 Magnetic Resonance SpectroscopyDiagnostic test
Cerebral MRI with Phosphorus 31 Magnetic Resonance Spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Experimental | 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. Receives: Diagnostic Test: Cerebral MRI with Phosphorus 31 Magnetic Resonance Spectroscopy |
| Control group | Active comparator | 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. Receives: Diagnostic Test: Cerebral MRI with Phosphorus 31 Magnetic Resonance Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of cellular inorganic phosphate between UHR-T and UHR-NT patients.
Levels measurements of inorganic phosphate.
Measured: 2 years
Difference of cellular phosphocreatine between UHR-T and UHR-NT patients.
Levels measurements of phosphocreatine.
Measured: 2 years
Difference of cellular Gamma ATP between UHR-T and UHR-NT patients.
Levels measurements of Gamma ATP.
Measured: 2 years
Difference of cellular Alpha ATP between UHR-T and UHR-NT patients.
Levels measurements of Alpha ATP.
Measured: 2 years
Difference of cellular beta ATP between UHR-T and UHR-NT patients.
Levels measurements of beta ATP.
Measured: 2 years
Difference of intracellular pH between UHR-T and UHR-NT patients.
Levels measurements of intracellular pH.
Measured: 2 years
Difference of membrane phosphodiester alterations between UHR-T and UHR-NT patients.
Levels measurements of phosphodiester.
Measured: 2 years
Difference of membrane phosphomonoester alterations between UHR-T and UHR-NT patients.
Levels measurements of phosphomonoester.
Measured: 2 years
Secondary outcomes (8)
Difference of cellular inorganic phosphate between UHR subjects and control subjects.
Levels measurements of inorganic phosphate.
Measured: 2 years
Difference of cellular phosphocreatine between UHR subjects and control subjects.
Levels measurements of phosphocreatine.
Measured: 2 years
Difference of cellular Gamma ATP between UHR subjects and control subjects.
Levels measurements of Gamma ATP.
Measured: 2 years
Difference of cellular Alpha ATP between UHR subjects and control subjects.
Levels measurements of Alpha ATP.
Measured: 2 years
Difference of cellular beta ATP between UHR subjects and control subjects.
Levels measurements of beta ATP.
Measured: 2 years
Difference of cellular intracellular pH between UHR subjects and control subjects.
Levels measurements of intracellular pH.
Measured: 2 years
Difference of membrane phosphodiester alterations between UHR subjects and control subjects.
Levels measurements of phosphodiester.
Measured: 2 years
Difference of membrane phosphomonoester alterations between UHR subjects and control subjects.
Levels measurements of phosphomonoester.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start2 May 2023
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Ultra High Risk of Psychotic TransitionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Laborit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865652
- Sponsor's protocol ID
- 2021-A02708-33
- Acronym
- MR7T-UHR
- Status last verified
- Oct 2026
- First submitted
- 21 Apr 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No