Bipolar Research And Innovation Network - BRAIN

Recruiting

• Conditions: Bipolar Disorder

• Registration Number: NCT00201526
• Lead Sponsor: Norwegian University of Science and Technology

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.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2030-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• All admitted patients giving written consent to participate in the study

Exclusion Criteria

• Patients without competence for consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in remission	15 years	Clinical Interview. Difference (MADRES) in remission between the study and control group.
Difference in response	15 years	Clinical Interview. Difference (MADRS) in response between the study and control group.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical Faculty, Norwegian University of Science And Technology; 🇳🇴 Trondheim, Norway