Bipolar Research And Innovation Network - BRAIN
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Difference in remission
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All admitted patients giving written consent to participate in the study
排除标准
- •Patients without competence for consent.
结局指标
主要结局
Difference in remission
时间窗: 15 years
Clinical Interview. Difference (MADRES) in remission between the study and control group.
Difference in response
时间窗: 15 years
Clinical Interview. Difference (MADRS) in response between the study and control group.
次要结局
- 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)
