Bipolar Research And Innovation Network - BRAIN

Bipolar Disorder Clinical Trial

Official title:

Bipolar Research And Innovation Network - BRAIN

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00201526
• Other study ID #: 10671
• Status: Recruiting
• Start date: January 2003
• Est. completion date: January 2030

Study information

• Verified date: October 2023
• Source: Norwegian University of Science and Technology
• Contact: Arne Vaaler, PhD MD
• Phone: +47 92090415
• Email: arne.e.vaaler[@]ntnu.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients without competence for consent.

Related Conditions & MeSH terms

• Bipolar Disorder

Locations

Country	Name	City	State
Norway	Medical Faculty, Norwegian University of Science And Technology	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in remission	Clinical Interview. Difference (MADRES) in remission between the study and control group.	15 years
Primary	Difference in response	Clinical Interview. Difference (MADRS) in response between the study and control group.	15 years
Secondary	GAF	Clinical Interview. Global Assessment of Function	15 years
Secondary	Current and concomitant medication	Clinical Interview.	1 year
Secondary	SF36	Clinical Interview.	1 year
Secondary	MADRS	Clinical Interview.	1 year
Secondary	IDS Inventory of depressive sympthoms	Clinical Interview.	1 year
Secondary	CGI-BP Clinical Global Index - Bipolar	Clinical Interview.	1 year
Secondary	PGI-1 (Patient global index)	Clinical Interview.	1 year
Secondary	YMRS (Young mania rating scale)	Clinical Interview.	1 year
Secondary	MSIF (Quality of life scale)	Clinical Interview.	1 year
Secondary	MMS (Minimal mental scale)	Clinical Interview.	1 year
Secondary	EMQ (Neuropsychology)	Clinical Interview.	1 year
Secondary	UKU (Medication side effects)	Clinical Interview.	1 year
Secondary	SAE-form (Serious adverse events)	Clinical Interview.	1 year
Secondary	Cytokines	Laboratory	1 year
Secondary	Cortisol	Laboratory	1 year
Secondary	Substance used	Laboratory, Urine	1 st week
Secondary	Compliance (medication)	Clinical interview	1 st year
Secondary	TEMPS-A (Temperament)	Clinical interview	Week 26
Secondary	Migraine (Clinical interview)	Clinical interview	Week 1 and week 26