Study of Bipolar Disorders and Retinal Electrophysiological Markers
- Conditions
- Bipolar Disorder
- Registration Number
- NCT05161546
- Lead Sponsor
- Centre Psychothérapique de Nancy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 62
Inclusion criteria :<br><br> 1. Patients:<br><br> - been diagnosed with BD according to the Diagnostic and Statistical Manual of<br> Mental Disorders - 4th edition (DSM-IV) diagnostic criteria using the Mini<br> International Neuropsychiatric Interview (MINI)<br><br> - currently euthymic for at least 3 months prior to the study, as defined by a<br> score below 10 on the Montgomery-Asberg Depression Rating Scale (MADRS) which<br> assesses depression and by a score below 8 on the Young Mania Rating Scale<br> (YMRS) which assesses mania<br><br> - age 18 or more<br><br> 2. Healthy volunteers:<br><br> - not suffer from a personal psychiatric pathology verified with the MINI<br><br> - age 18 or more<br><br>Exclusion criteria for all participants (patients and healthy volunteers):<br><br> - suffer from psychiatric pathology or substance use disorders according to DSM-IV<br> criteria measured with the MINI, excluding BD for the patient group<br><br> - suffer from neurological or retinal pathology<br><br> - having a shift work or a get-lag in the last 15 days<br><br> - criteria incompatible with the use of the virtual reality headset<br> (Retinaute®,BioSerenity) like having an allergy to one of the components of the<br> textile<br><br> - persons treated by sismotherapy during the past year<br><br> - persons with an uncorrected visual impairment or disabling hearing impairment that<br> does not allow neuropsychological tests to be performed<br><br> - subjects with an intellectual disability making it difficult to participate in the<br> study or to understand and follow informations provided to them<br><br> - adults legally protected<br><br> - pregnant or breastfeeding women<br><br> - subjects already participating in another interventional trial
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Modification of amplitude measured with flash and pattern electroretinogram;Modification of implicite time measured with flash and pattern electroretinogram
- Secondary Outcome Measures
Name Time Method Modification of amplitude measured with electroencephalogram;Modification of latency measured with electroencephalogram;Actigraphy;Sleep diary;Visual Object and Space Perception battery (VOSP);California Verbal Learning Test (CVLT);Continuous Performance Task (CPT-III);Verbal Fluency Task;Test of Attention Assessment (TAP);Montreal Cognitive Assessment (MoCA)