Clinical trial NCT00201526: Bipolar Research And Innovation Network - BRAIN
Official title: Bipolar Research And Innovation Network - BRAIN
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2005-09-20
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Secondary care clinics

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients without competence for consent.

Primary outcomes:
measure: Difference in remission
timeFrame: 15 years
measure: Difference in response
timeFrame: 15 years
Secondary outcomes:
measure: GAF
timeFrame: 15 years
measure: Current and concomitant medication
timeFrame: 1 year
measure: SF36
timeFrame: 1 year
measure: MADRS
timeFrame: 1 year
measure: IDS Inventory of depressive sympthoms
timeFrame: 1 year
measure: CGI-BP Clinical Global Index - Bipolar
timeFrame: 1 year
measure: PGI-1 (Patient global index)
timeFrame: 1 year
measure: YMRS (Young mania rating scale)
timeFrame: 1 year
measure: MSIF (Quality of life scale)
timeFrame: 1 year
measure: MMS (Minimal mental scale)
timeFrame: 1 year
measure: EMQ (Neuropsychology)
timeFrame: 1 year
measure: UKU (Medication side effects)
timeFrame: 1 year
measure: SAE-form (Serious adverse events)
timeFrame: 1 year
measure: Cytokines
timeFrame: 1 year
measure: Cortisol
timeFrame: 1 year
measure: Substance used
timeFrame: 1 st week
measure: Compliance (medication)
timeFrame: 1 st year
measure: TEMPS-A (Temperament)
timeFrame: Week 26
measure: Migraine (Clinical interview)
timeFrame: Week 1 and week 26
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Medical Faculty, Norwegian University of Science And Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: Gunnar Morken, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kessler U, Vaaler AE, Schoyen H, Oedegaard KJ, Bergsholm P, Andreassen OA, Malt UF, Morken G. The study protocol of the Norwegian randomized controlled trial of electroconvulsive therapy in treatment resistant depression in bipolar disorder. BMC Psychiatry. 2010 Feb 23;10:16. doi: 10.1186/1471-244X-10-16.
citation: Kessler U, Schoeyen HK, Andreassen OA, Eide GE, Hammar A, Malt UF, Oedegaard KJ, Morken G, Sundet K, Vaaler AE. Neurocognitive profiles in treatment-resistant bipolar I and bipolar II disorder depression. BMC Psychiatry. 2013 Apr 4;13:105. doi: 10.1186/1471-244X-13-105.
citation: Kessler U, Schoeyen HK, Andreassen OA, Eide GE, Malt UF, Oedegaard KJ, Morken G, Sundet K, Vaaler AE. The effect of electroconvulsive therapy on neurocognitive function in treatment-resistant bipolar disorder depression. J Clin Psychiatry. 2014 Nov;75(11):e1306-13. doi: 10.4088/JCP.13m08960.
citation: Schoeyen HK, Kessler U, Andreassen OA, Auestad BH, Bergsholm P, Malt UF, Morken G, Oedegaard KJ, Vaaler A. Treatment-resistant bipolar depression: a randomized controlled trial of electroconvulsive therapy versus algorithm-based pharmacological treatment. Am J Psychiatry. 2015 Jan;172(1):41-51. doi: 10.1176/appi.ajp.2014.13111517. Epub 2014 Oct 31.
citation: Bjoerke-Bertheussen J, Schoeyen H, Andreassen OA, Malt UF, Oedegaard KJ, Morken G, Sundet K, Vaaler AE, Auestad B, Kessler U. Right unilateral electroconvulsive therapy does not cause more cognitive impairment than pharmacologic treatment in treatment-resistant bipolar depression: A 6-month randomized controlled trial follow-up study. Bipolar Disord. 2018 Sep;20(6):531-538. doi: 10.1111/bdi.12594. Epub 2017 Dec 21.
citation: Drange OK, Saether SG, Finseth PI, Morken G, Vaaler AE, Arntsen V, Henning O, Andreassen OA, Elvsashagen T, Malt UF, Boen E. Differences in course of illness between patients with bipolar II disorder with and without epileptiform discharges or other sharp activity on electroencephalograms: a cross-sectional study. BMC Psychiatry. 2020 Dec 7;20(1):582. doi: 10.1186/s12888-020-02968-4.
citation: Drange OK, Vaaler AE, Morken G, Andreassen OA, Malt UF, Finseth PI. Clinical characteristics of patients with bipolar disorder and premorbid traumatic brain injury: a cross-sectional study. Int J Bipolar Disord. 2018 Sep 10;6(1):19. doi: 10.1186/s40345-018-0128-6.