跳至主要内容
临床试验/NCT00201526
NCT00201526招募中不适用

Bipolar Research And Innovation Network - BRAIN

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2003年1月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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