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NCT05650788
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
Conditions: Bipolar Disorder Type II, Mood Depressive Disorder
Sex: All
Ages: 18 Years – 40 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 60
Sponsor: University Hospital, Clermont-Ferrand
Location: France
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.
Eligibility Criteria
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 handedAged 18 to 40Having completed the MRI compatibility questionnaire and having no contraindication to MRIHaving given their written, free and informed consentAffiliated to a social security schemeEffective contraception for participants of childbearing ageECOG performance index < 2Exclusion criteria :Age < 18 or > 40BMI > 30kg/m2Current 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 consumption >3 units of alcohol/day (30g/day) for men and >2 units of alcohol/day (20g/day) for women.Unbalanced progressive condition (hepatic failure, renal failure with creatinine clearance <30mL/min, respiratory failure, congestive heart failure, myocardial infarction during the last 6 months, etc.)Any active cancerHolders of a pacemaker, cochlear implants, metallic implants or any magnetic elementClaustrophobiaPregnant and breastfeeding womenLegal incapacity (person deprived of liberty or under guardianship)Who, for psychological, social, family or geographical reasons, cannot be followed and/or compliant with the requirements of the studyAlready included in another clinical trialMOOD DEPRESSIVE DISORDERS GROUP :Inclusion criteria :Patients with a diagnosis of unipolar mood disorder stabilized in remission, according to DSM 5 criteria, with or without antidepressant treatment (SSRI, SNRI, tricyclics)Right handedAged 18 to 40Having completed the MRI compatibility questionnaire and having no contraindication to MRIHaving given their written, free and informed consentAffiliated to a social security schemeEffective contraception for participants of childbearing ageECOG performance index < 2Exclusion criteria :Age < 18 or > 40BMI > 30kg/m2Current 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 mood depressive 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 consumption >3 units of alcohol/day (30g/day) for men and >2 units of alcohol/day (20g/day) for women.Unbalanced progressive condition (hepatic failure, renal failure with creatinine clearance <30mL/min, respiratory failure, congestive heart failure, myocardial infarction during the last 6 months, etc.)Any active cancerHolders of a pacemaker, cochlear implants, metallic implants or any magnetic elementClaustrophobiaPregnant and breastfeeding womenLegal incapacity (person deprived of liberty or under guardianship)Who, for psychological, social, family or geographical reasons, cannot be followed and/or compliant with the requirements of the studyAlready included in another clinical trialHEALTHY GROUP :Inclusion criteria :People for whom no psychiatric diagnosis can be retained, according to DSM 5 criteria, naïve to psychotropic treatmentsRight handedAged 18 to 40Having completed the MRI compatibility questionnaire and having no contraindication to MRIHaving given their written, free and informed consentAffiliated to a social security schemeEffective contraception for participants of childbearing ageECOG performance index < 2Exclusion criteria :Age < 18 or > 40BMI > 30kg/m2Current 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 (e.g.
bipolar disorder, mood depressive disorder, 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 consumption >3 units of alcohol/day (30g/day) for men and >2 units of alcohol/day (20g/day) for women.Unbalanced progressive condition (hepatic failure, renal failure with creatinine clearance <30mL/min, respiratory failure, congestive heart failure, myocardial infarction during the last 6 months, etc.)Any active cancerHolders of a pacemaker, cochlear implants, metallic implants or any magnetic elementClaustrophobiaPregnant and breastfeeding womenLegal incapacity (person deprived of liberty or under guardianship)Who, for psychological, social, family or geographical reasons, cannot be followed and/or compliant with the requirements of the studyAlready included in another clinical trial
Source: ClinicalTrials.gov (NCT05650788). StuddyBuddy aggregates publicly available trial information.