Bipolar DisorderNCT00201526
Bipolar Research And Innovation Network - BRAIN
An observational study of Bipolar Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bipolar Disorder
- How many people
- 3,000 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2003to Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Secondary care clinics
Who may be able to join
- All admitted patients giving written consent to participate in the study
Who cannot join
- Patients without competence for consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Medical Faculty, Norwegian University of Science And Technology
Trondheim, 7441
Gunnar Morken, MD PhD, +4772823034, gunnar.morken@ntnu.no
Gunnar Morken, MD PhD
About this study
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.
Read the 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.
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | RCT | |
| Control group | RCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in remission
Clinical Interview. Difference (MADRES) in remission between the study and control group.
Measured: 15 years
Difference in response
Clinical Interview. Difference (MADRS) in response between the study and control group.
Measured: 15 years
Secondary outcomes (19)
GAF
Clinical Interview. Global Assessment of Function
Measured: 15 years
Current and concomitant medication
Clinical Interview.
Measured: 1 year
SF36
Clinical Interview.
Measured: 1 year
MADRS
Clinical Interview.
Measured: 1 year
IDS Inventory of depressive sympthoms
Clinical Interview.
Measured: 1 year
CGI-BP Clinical Global Index - Bipolar
Clinical Interview.
Measured: 1 year
PGI-1 (Patient global index)
Clinical Interview.
Measured: 1 year
YMRS (Young mania rating scale)
Clinical Interview.
Measured: 1 year
MSIF (Quality of life scale)
Clinical Interview.
Measured: 1 year
MMS (Minimal mental scale)
Clinical Interview.
Measured: 1 year
EMQ (Neuropsychology)
Clinical Interview.
Measured: 1 year
UKU (Medication side effects)
Clinical Interview.
Measured: 1 year
SAE-form (Serious adverse events)
Clinical Interview.
Measured: 1 year
Cytokines
Laboratory
Measured: 1 year
Cortisol
Laboratory
Measured: 1 year
Substance used
Laboratory, Urine
Measured: 1 st week
Compliance (medication)
Clinical interview
Measured: 1 st year
TEMPS-A (Temperament)
Clinical interview
Measured: Week 26
Migraine (Clinical interview)
Clinical interview
Measured: Week 1 and week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
- Investigators
- Gunnar Morken, PhD MD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201526
- Sponsor's protocol ID
- 10671
- Status last verified
- Dec 2025
- First submitted
- 16 Sep 2005
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20178636Kessler 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.
PubMed 23557429Kessler 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.
PubMed 25470096Schoeyen 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.
PubMed 25219389Bjoerke-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.
PubMed 29267990Drange 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.
PubMed 33287748Drange 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.
PubMed 30198055
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar Research And Innovation Network - BRAIN
- ClinicalTrials.gov ID
- NCT00201526
- Acronym / sponsor ID
- 10671
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Jan 2003 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –RCT |
| Control group | – | –RCT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Secondary care clinics
Key inclusion criteria (1 listed)
- All admitted patients giving written consent to participate in the study
Key exclusion criteria (1 listed)
- Patients without competence for consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in remission
Time frame: 15 years
Clinical Interview. Difference (MADRES) in remission between the study and control group.
Difference in response
Time frame: 15 years
Clinical Interview. Difference (MADRS) in response between the study and control group.
19 secondary outcomes
GAF
Time frame: 15 years
Current and concomitant medication
Time frame: 1 year
SF36
Time frame: 1 year
MADRS
Time frame: 1 year
IDS Inventory of depressive sympthoms
Time frame: 1 year
CGI-BP Clinical Global Index - Bipolar
Time frame: 1 year
PGI-1 (Patient global index)
Time frame: 1 year
YMRS (Young mania rating scale)
Time frame: 1 year
MSIF (Quality of life scale)
Time frame: 1 year
MMS (Minimal mental scale)
Time frame: 1 year
EMQ (Neuropsychology)
Time frame: 1 year
UKU (Medication side effects)
Time frame: 1 year
SAE-form (Serious adverse events)
Time frame: 1 year
Cytokines
Time frame: 1 year
Cortisol
Time frame: 1 year
Substance used
Time frame: 1 st week
Compliance (medication)
Time frame: 1 st year
TEMPS-A (Temperament)
Time frame: Week 26
Migraine (Clinical interview)
Time frame: Week 1 and week 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Background: PubMed 20178636Kessler 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.
- Background: PubMed 23557429Kessler 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.
- Background: PubMed 25470096Kessler 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.
- Background: PubMed 25219389Schoeyen 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.
- Background: PubMed 29267990Bjoerke-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.
- Derived from this study: PubMed 33287748Drange 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.
- Derived from this study: PubMed 30198055Drange 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gunnar Morken, PhD MD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arne Vaaler, PhD MD (+47 92090415, arne.e.vaaler@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in remission (time frame: 15 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00201526, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.