Bipolar Research And Innovation Network - BRAIN
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bipolar Disorder
- Sponsor
- Norwegian University of Science and Technology
- Enrollment
- 3000
- Locations
- 1
- Primary Endpoint
- Difference in remission
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
To describe the broad spectrum of Bipolar Disorder patients admitted to out-patient and in-patient psychiatric departments in Norway. Include all admitted Bipolar patients both with and without co-morbid disorders.
Detailed Description
Norway is both social, genetically and culturally a homogeneous society. The health service is public and has a nearly total responsibility for psychiatric care in given catchment areas. This provides excellent opportunities to describe the frequencies and patterns of the broad spectrum of bipolar illness, including co-morbid substance use disorders, to follow the patients for several years and to do molecular genetic mapping. Methods: Participating centers consist of outpatient clinics and hospital departments from different parts of Norway and one third-line clinic with referrals from all over Norway. Specifically trained clinicians in each center include bipolar patients systematically and perform the patient evaluation as part of their clinical duties. In addition, CT or MRI scans and EEG are performed and blood samples are collected for clinical chemistry screening and for DNA sampling.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All admitted patients giving written consent to participate in the study
Exclusion Criteria
- •Patients without competence for consent.
Outcomes
Primary Outcomes
Difference in remission
Time Frame: 15 years
Clinical Interview. Difference (MADRES) in remission between the study and control group.
Difference in response
Time Frame: 15 years
Clinical Interview. Difference (MADRS) in response between the study and control group.
Secondary Outcomes
- EMQ (Neuropsychology)(1 year)
- UKU (Medication side effects)(1 year)
- YMRS (Young mania rating scale)(1 year)
- CGI-BP Clinical Global Index - Bipolar(1 year)
- PGI-1 (Patient global index)(1 year)
- SAE-form (Serious adverse events)(1 year)
- Cortisol(1 year)
- GAF(15 years)
- Current and concomitant medication(1 year)
- SF36(1 year)
- MMS (Minimal mental scale)(1 year)
- Compliance (medication)(1 st year)
- TEMPS-A (Temperament)(Week 26)
- MADRS(1 year)
- IDS Inventory of depressive sympthoms(1 year)
- Cytokines(1 year)
- Migraine (Clinical interview)(Week 1 and week 26)
- MSIF (Quality of life scale)(1 year)
- Substance used(1 st week)