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NCT Number: NCT00201526

Bipolar Research And Innovation Network - BRAIN

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Faculty, Norwegian University of Science And Technology

Trondheim, 7441, Norway

Location status: Recruiting

Location contact

Gunnar Morken, MD PhD

CONTACT

[email protected]

+4772823034

Gunnar Morken, MD PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients without competence for consent.

Treatment and study plan

Primary outcomes

  1. Difference in remission

    Time frame: 15 years

    Clinical Interview. Difference (MADRES) in remission between the study and control group.

  2. Difference in response

    Time frame: 15 years

    Clinical Interview. Difference (MADRS) in response between the study and control group.

Secondary outcomes

  1. GAF

    Time frame: 15 years

    Clinical Interview. Global Assessment of Function

  2. Current and concomitant medication

    Time frame: 1 year

    Clinical Interview.

  3. SF36

    Time frame: 1 year

    Clinical Interview.

  4. MADRS

    Time frame: 1 year

    Clinical Interview.

  5. IDS Inventory of depressive sympthoms

    Time frame: 1 year

    Clinical Interview.

  6. CGI-BP Clinical Global Index - Bipolar

    Time frame: 1 year

    Clinical Interview.

  7. PGI-1 (Patient global index)

    Time frame: 1 year

    Clinical Interview.

  8. YMRS (Young mania rating scale)

    Time frame: 1 year

    Clinical Interview.

  9. MSIF (Quality of life scale)

    Time frame: 1 year

    Clinical Interview.

  10. MMS (Minimal mental scale)

    Time frame: 1 year

    Clinical Interview.

  11. EMQ (Neuropsychology)

    Time frame: 1 year

    Clinical Interview.

  12. UKU (Medication side effects)

    Time frame: 1 year

    Clinical Interview.

  13. SAE-form (Serious adverse events)

    Time frame: 1 year

    Clinical Interview.

  14. Cytokines

    Time frame: 1 year

    Laboratory

  15. Cortisol

    Time frame: 1 year

    Laboratory

  16. Substance used

    Time frame: 1 st week

    Laboratory, Urine

  17. Compliance (medication)

    Time frame: 1 st year

    Clinical interview

  18. TEMPS-A (Temperament)

    Time frame: Week 26

    Clinical interview

  19. Migraine (Clinical interview)

    Time frame: Week 1 and week 26

    Clinical interview

Study contacts

Contact information is provided by the study sponsor or research team.

Arne Vaaler, PhD MD

CONTACT

[email protected]

+47 92090415

Gunnar Morken, PhD MD

CONTACT

[email protected]

+47 72823034

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • University of Oslo

Registry information

Important dates

Study start
2003
Primary completion
2030
Study completion
2030
First posted
Sep 20, 2005
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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