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NCT05650788Befejeződött

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. jan. 30.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
60 (tényleges)
Első benyújtás
2022. nov. 21.
Kezdés
2020. jún. 5.
Elsődleges befejezés
2024. júl. 17.
Fő szponzor
University Hospital, Clermont-Ferrand
Betegségek
Bipoláris zavar
NCT-szám
NCT05650788

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Bevont résztvevők: 60
  • 2020. jún. 5. és az elsődleges befejezés (2024. júl. 17.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • 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

Más betegség

  • 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

Laborértékek

  • 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.)

Életkor

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

Egyéb

  • 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

Kiket keres a vizsgálat

  • 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

A regiszterben nem jelölt feltételek

  • BIPOLAR DISORDERS GROUP :

Életkor a regiszterben: 18 év – 40 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
CHU Clermont-FerrandClermont-FerrandFranciaországIsmeretlen állapot

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