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NCT05650788Completed

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

Source: ClinicalTrials.gov · Last updated 30 Jan 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
60 (actual)
First submitted
21 Nov 2022
Start date
5 Jun 2020
Primary completion date
17 Jul 2024
Lead sponsor
University Hospital, Clermont-Ferrand
NCT number
NCT05650788

What you commit to

  • Study type: Interventional
  • Participants enrolled: 60
  • From 5 Jun 2020 to the primary completion date, 17 Jul 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Holders of a pacemaker, cochlear implants, metallic implants or any magnetic element
  • 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.
  • Holders of a pacemaker, cochlear implants, metallic implants or any magnetic element
  • 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.
  • Holders of a pacemaker, cochlear implants, metallic implants or any magnetic element

Other illness

  • 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.)
  • Any active cancer
  • Already included in another clinical trial
    • MOOD DEPRESSIVE DISORDERS GROUP :
  • 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.)
  • Any active cancer
  • 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.)
  • Any active cancer

Lab values

  • 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.)
  • 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.)
  • 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.)

Age

  • Age \< 18 or \> 40
  • Age \< 18 or \> 40
  • Age \< 18 or \> 40

Other

  • BMI \> 30kg/m2
  • Current episode. (MADRS score \> 15 or YMRS score \> 12, Montgomery, 1979, Young et al, 1978)
  • Alcohol consumption \>3 units of alcohol/day (30g/day) for men and \>2 units of alcohol/day (20g/day) for women.
  • 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
  • BMI \> 30kg/m2
  • Current episode. (MADRS score \> 15 or YMRS score \> 12, Montgomery, 1979, Young et al, 1978)
  • Alcohol consumption \>3 units of alcohol/day (30g/day) for men and \>2 units of alcohol/day (20g/day) for women.
  • 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 :
  • BMI \> 30kg/m2
  • Current episode. (MADRS score \> 15 or YMRS score \> 12, Montgomery, 1979, Young et al, 1978)
  • Alcohol consumption \>3 units of alcohol/day (30g/day) for men and \>2 units of alcohol/day (20g/day) for women.
  • 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

Who the study is looking for

  • 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
  • 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
  • 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

Criteria the registry did not label

  • BIPOLAR DISORDERS GROUP :

Age in the registry: 18 years to 40 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Clermont-Ferrand
Coordinator of this site? Confirm its status		Clermont-FerrandFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.