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Bipolar Research And Innovation Network - BRAIN

Bipolar Research And Innovation Network - BRAIN

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00201526
Enrollment
3000
Registered
2005-09-20
Start date
2003-01-31
Completion date
2030-01-31
Last updated
2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder

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.

Interventions

None listed

Sponsors

University of Oslo
CollaboratorOTHER
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Patients without competence for consent.

Design outcomes

Primary

MeasureTime frameDescription
Difference in remission15 yearsClinical Interview. Difference (MADRES) in remission between the study and control group.
Difference in response15 yearsClinical Interview. Difference (MADRS) in response between the study and control group.

Secondary

MeasureTime frameDescription
SF361 yearClinical Interview.
MADRS1 yearClinical Interview.
IDS Inventory of depressive sympthoms1 yearClinical Interview.
CGI-BP Clinical Global Index - Bipolar1 yearClinical Interview.
PGI-1 (Patient global index)1 yearClinical Interview.
YMRS (Young mania rating scale)1 yearClinical Interview.
MSIF (Quality of life scale)1 yearClinical Interview.
MMS (Minimal mental scale)1 yearClinical Interview.
GAF15 yearsClinical Interview. Global Assessment of Function
UKU (Medication side effects)1 yearClinical Interview.
SAE-form (Serious adverse events)1 yearClinical Interview.
Cytokines1 yearLaboratory
Cortisol1 yearLaboratory
Substance used1 st weekLaboratory, Urine
Compliance (medication)1 st yearClinical interview
TEMPS-A (Temperament)Week 26Clinical interview
Migraine (Clinical interview)Week 1 and week 26Clinical interview
EMQ (Neuropsychology)1 yearClinical Interview.
Current and concomitant medication1 yearClinical Interview.

Countries

Norway

Contacts

Primary ContactArne Vaaler, PhD MD
arne.e.vaaler@ntnu.no+47 92090415
Backup ContactGunnar Morken, PhD MD
gunnar.morken@ntnu.no+47 72823034

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026