CompletedNot Applicable

Exploration of Differences in Metabolite Concentrations by NMR Spectroscopy in the Ventral Striatum, Anterior Cingulate Cortex and Prefrontal Cortex in Euthymic Patients With Unipolar and Bipolar Type II Mood Disorders, as Well as in Healthy Subjects

France60 participantsStarted 2020-06-05

Plain-language summary

The presented project is an open and controlled single-center prospective exploratory study, evaluating the metabolic concentrations in the ventral striatum (VS), the Anterior cingulate cortex (ACC) and the prefrontal cortex (PFC) on the left and on the right of patients in remission of unipolar mood disorder and type II bipolar mood disorder compared to each other and to healthy subjects using NMR spectrometric measurements. We hypothesize that there is a significant difference between the mean glutamate concentrations in the ventral striatum (right and left) of the two groups of unipolar and bipolar type II patients. The average glutamate concentration would be higher for participants in the group of type II bipolar patients.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

BIPOLAR DISORDERS GROUP : Inclusion criteria : * Patients with a diagnosis of bipolar type II disorder stabilized in remission, according to DSM 5 criteria, with mood stabilizer treatment (lithium, anticonvulsant or antipsychotic) at an effective dose, with possible antidepressant treatment (SSRI, SNRI, tricyclics ) * Right handed * Aged 18 to 40 * Having completed the MRI compatibility questionnaire and having no contraindication to MRI * Having given their written, free and informed consent * Affiliated to a social security scheme * Effective contraception for participants of childbearing age * ECOG performance index \< 2 Exclusion criteria : * Age \< 18 or \> 40 * BMI \> 30kg/m2 * Current episode. (MADRS score \> 15 or YMRS score \> 12, Montgomery, 1979, Young et al, 1978) * Unbalanced psychiatric pathology. * Neurological pathology (e.g. parkinsonian syndrome, stroke, migraine, fibromyalgia, etc.) * Psychiatric pathology other than bipolar mood disorder (e.g. schizophrenia, severe anxiety disorder, severe personality disorder, instinctual behavior disorder, autism spectrum disorder, disorder related to the use of psychoactive substances excluding tobacco.) * Under current psychotropic treatment other than antidepressants (SSRI, SNRI, tricyclics) or mood stabilizer (lithium, anticonvulsant or antipsychotic) at an effective dose. Treatment with benzodiazepine possible if possibility of deferring this line of treatment when carrying out the NMR acquisition. * Alcohol con…

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
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Questions for the trial coordinator

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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
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6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Glutamate concentration in ventral striatum

Timeframe: Within 3 months after inclusion

Trial details

NCT IDNCT05650788

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-17

View on ClinicalTrials.gov More Bipolar Disorder Type II trials