Study of Bipolar Disorders and Retinal Electrophysiological Markers (BIMAR)
Bipolar Disorder
About this trial
This is an interventional diagnostic trial for Bipolar Disorder focused on measuring bipolar disorder, biomarker, electroretinogram, electroencephalogram, neurocognition, actigraphy, retina
Eligibility Criteria
Inclusion criteria :
Patients:
- been diagnosed with BD according to the Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) diagnostic criteria using the Mini International Neuropsychiatric Interview (MINI)
- currently euthymic for at least 3 months prior to the study, as defined by a score below 10 on the Montgomery-Asberg Depression Rating Scale (MADRS) which assesses depression and by a score below 8 on the Young Mania Rating Scale (YMRS) which assesses mania
- age 18 or more
Healthy volunteers:
- not suffer from a personal psychiatric pathology verified with the MINI
- age 18 or more
Exclusion criteria for all participants (patients and healthy volunteers):
- suffer from psychiatric pathology or substance use disorders according to DSM-IV criteria measured with the MINI, excluding BD for the patient group
- suffer from neurological or retinal pathology
- having a shift work or a get-lag in the last 15 days
- criteria incompatible with the use of the virtual reality headset (Retinaute®,BioSerenity) like having an allergy to one of the components of the textile
- persons treated by sismotherapy during the past year
- persons with an uncorrected visual impairment or disabling hearing impairment that does not allow neuropsychological tests to be performed
- subjects with an intellectual disability making it difficult to participate in the study or to understand and follow informations provided to them
- adults legally protected
- pregnant or breastfeeding women
- subjects already participating in another interventional trial
Sites / Locations
- Centre Psychothérapique de NancyRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
patients with bipolar disorder (BD)
healthy volunteers
Electrophysiological recordings with ERG and EEG will be performed with a virtual reality headset after a standardized clinical evaluation (first visit). Then, an actigraphic monitoring of 21 consecutive days will be carried out. At the end of this period a neuropsychological evaluation will be performed during a second visit. Between day 23 and day 28 (after the second visit), patients will be offered to assess the retinal structure and microvascularization using Spectral Domain Optical Coherence Tomography (SD-OCT) and OCT-Angiography (OCT-A).
Electrophysiological recordings with ERG and EEG will be performed with a virtual reality headset after a standardized clinical evaluation (first visit). Then, an actigraphic monitoring of 21 consecutive days will be carried out. At the end of this period a neuropsychological evaluation will be performed during a second visit.