Bipolar Disorder Type IIRMN-UNIBINCT05650788
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
A study testing NMR spectrometry in people with Bipolar Disorder Type II and Mood Depressive Disorder, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder Type II, Mood Depressive Disorder
- What is being tested?
- NMR spectrometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2020to 17 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 24Show fewer
- 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
Who cannot join
- 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.)
Show all 50Show fewer
- 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 :
- 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 :
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Depression meets the same clinical diagnostic criteria whether it is the expression of a bipolar or unipolar mood disorder. It is essential to distinguish between these two disorders because the pharmacological management of this episode and the follow-up of the patient will be different. The risk of iatrogenesis is significant if the diagnosis is incorrect. Currently, there is no biomarker that can help the clinician in his diagnostic approach and to differentiate between bipolar and unipolar mood disorder (Grande et al., 2016; Vieta et al., 2018).
Many research, particularly in neuroimaging, explore these mood disorders to identify morphological, functional and metabolic signatures both in the state phase and in the asymptomatic phase.
Functional imaging work, carried out at the Cardiff University Brain Research Imaging Center in Wales in collaboration with the team 7280 from Clermont Auvergne University, is part of this research. The object of this work was to study the dopaminergic system, and in particular the meso-cortico-limbic pathway, which is the anatomical and functional substrate of the reward circuit. The activity of this system, when measured on functional MRI in the ventral striatum during an activation paradigm of the "anticipation of a reward during a monetary task" type, shows variations in the disorders of mood, in the state phase as well as in the asymptomatic phase. These activation differences are significantly different between healthy, unipolar and bipolar asymptomatic subjects.
The cerebral neurochemical processes involved in the physiopathology of mood disorders being still little studied at the present time and in order to complete these observations, the measurement and comparison of the concentrations of metabolites by NMR spectroscopy in these same regions (the meso -cortico-limbic) and under these same conditions will make it possible to specify the physiopathology of mood disorders. NMR spectroscopy, unlike functional MRI, allows us not only to compare groups, but also to measure concentrations in absolute values. Data from the literature show that these explorations are feasible in humans and meta-analyses suggest that a direct comparison could make it possible to discriminate mood disorders by the clinical dimension "capacity to experience pleasure" - or "hedonic capacity".
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.
This exploratory study will allow a better understanding of the pathophysiological mechanisms involved in the development of mood disorders and in particular in their clinical dimension "hedonic capacity", as well as to test the relevance of this potential biomarker (glutamate) than the current state of Art allows us to consider. The measurements in the control group will allow us to approach the values of the physiological norm. The measurements in the clinical groups will allow us to understand whether the "mood disorder" condition, even in remission, constitutes a sufficient factor of variation in this standard to allow them to be detected. This work would represent a first fundamental step in the understanding of pathophysiological mechanisms and the establishment of this measure as a biomarker for screening mood disorders and for discriminating between a unipolar disorder and a bipolar disorder and could thus guide the clinician in his diagnostic and therapeutic approach.
The constraints for the participants will be minimal with only two visits to the CHU. A first for the inclusion of a duration of 60 minutes. A second for the 120-minute measurement visit. The inclusion of patients will be done if possible during their regular follow-up to limit travel. Since MRI is a non-invasive technique used routinely in hospital practice, the risks incurred by patients are almost nil, subject to compliance with the contraindications of MRI
- Conditions
- Bipolar Disorder Type II, Mood Depressive Disorder
- Being tested
- NMR spectrometry
- Keywords
- Bipolar disorder, Mood depressive disorder, RMN exploration, Metabolites concentration
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMR spectrometryDiagnostic test
The MRI protocol will be carried out at 3 Tesla (3T) on a Siemens NMR imaging system (Magnetom Vida, Siemens Healthcare, Erlangen, Germany), the emission of radiofrequency waves and the reception of the signal will be done using a resonator in quadrature head (64-channel phase-array antenna). The MRI protocol will take place in two phases:
- Realization of a morphological sequence for the identification of the zone of interest.
- Acquisition of a 1D NMR spectrum in the ventral striatum (right and left).
- Acquisition of a 1D NMR spectrum in the anterior cingulate cortex (right and left).
- Acquisition of a 1D NMR spectrum in the prefrontal cortex (right and left).
| Study group | Role | What they receive |
|---|---|---|
| Bipolar disorder group | Experimental | Patients with a diagnosis of bipolar II mood 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 ) Receives: Diagnostic Test: NMR spectrometry |
| Mood depressive disorder group | Experimental | Patients with a diagnosis of unipolar mood disorder stabilized in remission, according to DSM 5 criteria, with or without antidepressant treatment (SSRI, SNRI, tricyclics) Receives: Diagnostic Test: NMR spectrometry |
| Healthy volunteer | Experimental | People for whom no psychiatric diagnosis can be retained, according to DSM 5 criteria and naïve to psychotropic treatments Receives: Diagnostic Test: NMR spectrometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glutamate concentration in ventral striatum
The main objective of the study is to compare the mean concentrations of glutamate in the ventral striatum (right and left), between two groups of treated, asymptomatic patients: unipolar vs bipolar type II disorder. Patients will also be compared to a sample of healthy controls.
Measured: Within 3 months after inclusion
Secondary outcomes (9)
Metabolites concentration in interest structures
Comparison of mean concentrations of metabolites (Choline, myo-inositol, N-acetylaspartate, creatine, glutamate/glutamine, lactate, taurine, GABA) in the Ventral Striatum (VS), Anterior Cingulate Cortex (ACC) and Prefrontal Cortex (PFC) ) between the three groups
Measured: Within 3 months after inclusion
Metabolites relationships with Seniority, severity of the disorder
Study of the relationships between the concentrations of metabolites with Seniority, severity of the disorder measured by MADRS questionnaire
Measured: Within 3 months after inclusion
Metabolites relationships with Predominant polarity
Study of the relationships between the concentrations of metabolites with Predominant polarity by YMRS questionnaire
Measured: Within 3 months after inclusion
Metabolites relationships with Dimension Anhedonia
Study of the relationships between the concentrations of metabolites with Dimension Anhedonia by SHAP questionnaire
Measured: Within 3 months after inclusion
Metabolites relationships with Operation
Study of the relationships between the concentrations of metabolites with Operation by FAST questionnaire
Measured: Within 3 months after inclusion
Metabolites relationships with Quality of life by MARS questionnaire
Study of the relationships between the concentrations of metabolites with Quality of life
Measured: Within 3 months after inclusion
Metabolites relationships with Compliance with treatment
Study of the relationships between the concentrations of metabolites with Compliance with treatment by WHOQOL-BREF questionnaire
Measured: Within 3 months after inclusion
Metabolites relationships with description ofPharmacological class of the antidepressant
Study of the relationships between the concentrations of metabolites with Pharmacological class of the antidepressant by
Measured: Within 3 months after inclusion
Metabolites relationships with description of Pharmacological class of mood stabilizer.
Study of the relationships between the concentrations of metabolites with description of Pharmacological class of mood stabilizer.
Measured: Within 3 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start5 Jun 2020
- Primary completion17 Jul 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder Type IIStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne ALLAUZE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650788
- Sponsor's protocol ID
- AOI 2019 ALLAUZE
- Other IDs
- 2019-A02607-50
- Acronym
- RMN-UNIBI
- Status last verified
- Jan 2025
- First submitted
- 21 Nov 2022
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05650788
- Acronym / sponsor ID
- RMN-UNIBI / AOI 2019 ALLAUZE
- Conditions
- Bipolar Disorder Type II, Mood Depressive Disorder
- Keywords
- Bipolar disorder, Mood depressive disorder, RMN exploration, Metabolites concentration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Depression meets the same clinical diagnostic criteria whether it is the expression of a bipolar or unipolar mood disorder. It is essential to distinguish between these two disorders because the pharmacological management of this episode and the follow-up of the patient will be different. The risk of iatrogenesis is significant if the diagnosis is incorrect. Currently, there is no biomarker that can help the clinician in his diagnostic approach and to differentiate between bipolar and unipolar mood disorder (Grande et al., 2016; Vieta et al., 2018).
Many research, particularly in neuroimaging, explore these mood disorders to identify morphological, functional and metabolic signatures both in the state phase and in the asymptomatic phase.
Functional imaging work, carried out at the Cardiff University Brain Research Imaging Center in Wales in collaboration with the team 7280 from Clermont Auvergne University, is part of this research. The object of this work was to study the dopaminergic system, and in particular the meso-cortico-limbic pathway, which is the anatomical and functional substrate of the reward circuit. The activity of this system, when measured on functional MRI in the ventral striatum during an activation paradigm of the "anticipation of a reward during a monetary task" type, shows variations in the disorders of mood, in the state phase as well as in the asymptomatic phase. These activation differences are significantly different between healthy, unipolar and bipolar asymptomatic subjects.
The cerebral neurochemical processes involved in the physiopathology of mood disorders being still little studied at the present time and in order to complete these observations, the measurement and comparison of the concentrations of metabolites by NMR spectroscopy in these same regions (the meso -cortico-limbic) and under these same conditions will make it possible to specify the physiopathology of mood disorders. NMR spectroscopy, unlike functional MRI, allows us not only to compare groups, but also to measure concentrations in absolute values. Data from the literature show that these explorations are feasible in humans and meta-analyses suggest that a direct comparison could make it possible to discriminate mood disorders by the clinical dimension "capacity to experience pleasure" - or "hedonic capacity".
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.
This exploratory study will allow a better understanding of the pathophysiological mechanisms involved in the development of mood disorders and in particular in their clinical dimension "hedonic capacity", as well as to test the relevance of this potential biomarker (glutamate) than the current state of Art allows us to consider. The measurements in the control group will allow us to approach the values of the physiological norm. The measurements in the clinical groups will allow us to understand whether the "mood disorder" condition, even in remission, constitutes a sufficient factor of variation in this standard to allow them to be detected. This work would represent a first fundamental step in the understanding of pathophysiological mechanisms and the establishment of this measure as a biomarker for screening mood disorders and for discriminating between a unipolar disorder and a bipolar disorder and could thus guide the clinician in his diagnostic and therapeutic approach.
The constraints for the participants will be minimal with only two visits to the CHU. A first for the inclusion of a duration of 60 minutes. A second for the 120-minute measurement visit. The inclusion of patients will be done if possible during their regular follow-up to limit travel. Since MRI is a non-invasive technique used routinely in hospital practice, the risks incurred by patients are almost nil, subject to compliance with the contraindications of MRI
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bipolar disorder group | Experimental | Diagnostic Test: NMR spectrometryPatients with a diagnosis of bipolar II mood 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 ) |
| Mood depressive disorder group | Experimental | Diagnostic Test: NMR spectrometryPatients with a diagnosis of unipolar mood disorder stabilized in remission, according to DSM 5 criteria, with or without antidepressant treatment (SSRI, SNRI, tricyclics) |
| Healthy volunteer | Experimental | Diagnostic Test: NMR spectrometryPeople for whom no psychiatric diagnosis can be retained, according to DSM 5 criteria and naïve to psychotropic treatments |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- 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
Key exclusion criteria (50 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMR spectrometryThe MRI protocol will be carried out at 3 Tesla (3T) on a Siemens NMR imaging system (Magnetom Vida, Siemens Healthcare, Erlangen, Germany), the emission of radiofrequency waves and the reception of the signal will be done using a resonator in quadrature head (64-channel phase-array antenna). The MRI protocol will take place in two phases: * Realization of a morphological sequence for the identification of the zone of interest. * Acquisition of a 1D NMR spectrum in the ventral striatum (right and left). * Acquisition of a 1D NMR spectrum in the anterior cingulate cortex (right and left). * Acquisition of a 1D NMR spectrum in the prefrontal cortex (right and left). | Diagnostic test | Bipolar disorder group, Healthy volunteer, Mood depressive disorder group |
Primary outcome
Glutamate concentration in ventral striatum
Time frame: Within 3 months after inclusion
The main objective of the study is to compare the mean concentrations of glutamate in the ventral striatum (right and left), between two groups of treated, asymptomatic patients: unipolar vs bipolar type II disorder. Patients will also be compared to a sample of healthy controls.
9 secondary outcomes
Metabolites concentration in interest structures
Time frame: Within 3 months after inclusion
Metabolites relationships with Seniority, severity of the disorder
Time frame: Within 3 months after inclusion
Metabolites relationships with Predominant polarity
Time frame: Within 3 months after inclusion
Metabolites relationships with Dimension Anhedonia
Time frame: Within 3 months after inclusion
Metabolites relationships with Operation
Time frame: Within 3 months after inclusion
Metabolites relationships with Quality of life by MARS questionnaire
Time frame: Within 3 months after inclusion
Metabolites relationships with Compliance with treatment
Time frame: Within 3 months after inclusion
Metabolites relationships with description ofPharmacological class of the antidepressant
Time frame: Within 3 months after inclusion
Metabolites relationships with description of Pharmacological class of mood stabilizer.
Time frame: Within 3 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne ALLAUZE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMR spectrometry in people with Bipolar Disorder Type II and Mood Depressive Disorder, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 50 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glutamate concentration in ventral striatum (time frame: Within 3 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.