Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 April 2022 |
Main ID: |
NCT03496285 |
Date of registration:
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05/04/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Accumbofrontal Tract Study in 2 Populations of Patients With Anorexia Nervosa and Obsessional Compulsive Disorder and Healthy Volunteer
ACCUMBENS |
Scientific title:
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Multimodal MRI Study of Accumbofrontal Tract in Anorexia Nervosa and Obessional Compulsive Disorder : Search for Structural and Functional Changes Between Orbito-frontal Cortex and Accumbens Nucleus Subdivisions |
Date of first enrolment:
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May 9, 2018 |
Target sample size:
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30 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03496285 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female patients
- Age between 18 and 65 years
- Subjects free to give their written consent
For anorexia nervosa :
- Patients meeting the diagnostic criteria for anorexia nervosa according to DSM5
(American Psychiatric Association): low weight (<85% of expected weight for age and
height), fear of gaining weight or becoming fat, distortion of body image, and
amenorrhea for more than 3 months
- Treatment with at least one antidepressant and one anxiolytic
For OCD :
- Patients meeting the diagnostic criteria of OCDs according to DSM5 (American
Psychiatric Association) : presence of obsessions and / or compulsions, resulting in
clinically significant suffering (loss of at least one hour per day) or impairment at
the social, occupational level or in another important area of life. These symptoms
are not due to the physiological effects of a substance or a general medical condition
and cannot be better explained by the symptoms of another psychiatric disorder.
- Patients with homogeneous OCD in obsession and compulsion.
- Normal weight compared to expected weight for age and height
- Treatment with at least one antidepressant and one anxiolytic
ForHealthy volunteer
•Normal weight compared to expected weight for age and height
Exclusion Criteria:
- Male
- Age <18 years or> 65 years
- Pregnancy
- Absence of free and informed consent signature
- Current processing by rTMS
- Somatic intercurrent pathologies: neurological, cardiological, pneumological, renal,
hepatic, endocrine, metabolic disorders ...
- Mental retardation (WAIS-IV QI <70)
- Primary Amenorrhea
- Absolute contraindication or relative to the realization of a magnetic resonance
imaging without injection of contrast medium
- Old or intercurrent psychotic pathology
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Accumbo Frontal Tract
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Intervention(s)
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Radiation: Multimodal MRI with diffusion sequence for anorexia nervosa patient
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Radiation: Multimodal MRI with diffusion sequence for healthy volunteer
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Radiation: Multimodal MRI with diffusion sequence for obsessional compulsive disorder patient
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Primary Outcome(s)
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Fractional Anisotropy (probabilistic tractography)
[Time Frame: 20 minutes]
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Secondary Outcome(s)
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BOLD Signal (resting state)
[Time Frame: 20 minutes]
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Secondary ID(s)
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ACCUMBENS
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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