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

Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · Dec 6, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the differences in certain brain chemicals, specifically glutamate, in individuals with bipolar disorder type II and unipolar mood disorders who are currently stable and in remission. The goal is to compare these levels with those of healthy individuals to see if there are significant differences. Researchers will use a technique called NMR spectroscopy to measure these chemical concentrations in specific areas of the brain.

To participate in this study, you must be between 18 and 40 years old, right-handed, and have a diagnosis of either bipolar type II disorder or unipolar mood disorder, both in remission. Participants will need to be on a stable treatment plan with mood stabilizers and may also take certain antidepressants. If you choose to take part, you'll undergo some non-invasive brain scans and answer questions about your health. It's important to understand that certain health conditions and treatments may exclude you from joining the trial. Your involvement could help improve our understanding of mood disorders and how they affect brain chemistry.

Gender

ALL

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 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 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 cancer
• • Holders of a pacemaker, cochlear implants, metallic implants or any magnetic element
• • Claustrophobia
• • Pregnant and breastfeeding women
• • Legal 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 study
• • Already included in another clinical trial
• MOOD 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 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 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 cancer
• • Holders of a pacemaker, cochlear implants, metallic implants or any magnetic element
• • Claustrophobia
• • Pregnant and breastfeeding women
• • Legal 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 study
• • Already included in another clinical trial
• HEALTHY GROUP :
• Inclusion criteria :
• • People for whom no psychiatric diagnosis can be retained, according to DSM 5 criteria, naïve to psychotropic treatments
• • 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 (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 cancer
• • Holders of a pacemaker, cochlear implants, metallic implants or any magnetic element
• • Claustrophobia
• • Pregnant and breastfeeding women
• • Legal 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 study
• • Already included in another clinical trial

Trial Officials