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MR7T-UHRNCT05865652

Evaluation of Membrane Phospholipid and Energy Metabolism in Subjects at High Risk of Psychotic Transition

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved at least 1 year 11 months later.

See at-risk trials from Centre Hospitalier Henri Laborit

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Record History

All 5 versions: 4 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from May 2026 to May 2028
    • Eligibility criteria expanded, about 13 words
  2. Primary and study completion dates: May 2025 to May 2026v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 15, 2023 to May 2, 2023
    • Site details revised
    v2
  4. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Difference of cellular inorganic phosphate between UHR-T and UHR-NT patients.
Timeframe: 2 years
Difference of cellular phosphocreatine between UHR-T and UHR-NT patients.
Timeframe: 2 years
Difference of cellular Gamma ATP between UHR-T and UHR-NT patients.
Timeframe: 2 years
Difference of cellular Alpha ATP between UHR-T and UHR-NT patients.
Timeframe: 2 years
Difference of cellular beta ATP between UHR-T and UHR-NT patients.
Timeframe: 2 years
Difference of intracellular pH between UHR-T and UHR-NT patients.
Timeframe: 2 years
Difference of membrane phosphodiester alterations between UHR-T and UHR-NT patients.
Timeframe: 2 years
Difference of membrane phosphomonoester alterations between UHR-T and UHR-NT patients.
Timeframe: 2 years

Secondary (8)

Difference of cellular inorganic phosphate between UHR subjects and control subjects.
Difference of cellular phosphocreatine between UHR subjects and control subjects.
Difference of cellular Gamma ATP between UHR subjects and control subjects.
Difference of cellular Alpha ATP between UHR subjects and control subjects.
Difference of cellular beta ATP between UHR subjects and control subjects.
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Difference of cellular intracellular pH between UHR subjects and control subjects.
Difference of membrane phosphodiester alterations between UHR subjects and control subjects.
Difference of membrane phosphomonoester alterations between UHR subjects and control subjects.

Arms and interventions

Patient groupExperimental

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.

Control groupActive 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.

Diagnostic tests: Cerebral MRI with Phosphorus 31 Magnetic Resonance Spectroscopy

Sites

1 site in 1 country

  • Centre Hospitalier Henri LaboritPoitiers, France