Bipolar Research And Innovation Network - BRAIN

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bipolar Research And Innovation Network - BRAIN

Conditions
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Bipolar Disorder

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All admitted patients giving written consent to participate in the study Exclusion Criteria: Patients without competence for consent.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>RCT | |
| Control group<br>RCT | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in remission | Clinical Interview. Difference (MADRES) in remission between the study and control group. | 15 years | 
| Difference in response | Clinical Interview. Difference (MADRS) in response between the study and control group. | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GAF | Clinical Interview. Global Assessment of Function | 15 years | 
| Current and concomitant medication | Clinical Interview. | 1 year | 
| SF36 | Clinical Interview. | 1 year | 
| MADRS | Clinical Interview. | 1 year | 
| IDS Inventory of depressive sympthoms | Clinical Interview. | 1 year | 
| CGI-BP Clinical Global Index - Bipolar | Clinical Interview. | 1 year | 
| PGI-1 (Patient global index) | Clinical Interview. | 1 year | 
| YMRS (Young mania rating scale) | Clinical Interview. | 1 year | 
| MSIF (Quality of life scale) | Clinical Interview. | 1 year | 
| MMS (Minimal mental scale) | Clinical Interview. | 1 year | 
| EMQ (Neuropsychology) | Clinical Interview. | 1 year | 
| UKU (Medication side effects) | Clinical Interview. | 1 year | 
| SAE-form (Serious adverse events) | Clinical Interview. | 1 year | 
| Cytokines | Laboratory | 1 year | 
| Cortisol | Laboratory | 1 year | 
| Substance used | Laboratory, Urine | 1 st week | 
| Compliance (medication) | Clinical interview | 1 st year | 
| TEMPS-A (Temperament) | Clinical interview | Week 26 | 
| Migraine (Clinical interview) | Clinical interview | Week 1 and week 26 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar Disorder