NCT00201526

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Jan 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Jan 2003Jan 2030

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
24.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

27 years

First QC Date

September 16, 2005

Last Update Submit

December 5, 2025

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder

Outcome Measures

Primary Outcomes (2)

  • Difference in remission

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

    15 years

  • Difference in response

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

    15 years

Secondary Outcomes (19)

  • GAF

    15 years

  • Current and concomitant medication

    1 year

  • SF36

    1 year

  • MADRS

    1 year

  • IDS Inventory of depressive sympthoms

    1 year

  • +14 more secondary outcomes

Study Arms (2)

Study group

RCT

Control group

RCT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Secondary care clinics

You may qualify if:

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

You may not qualify if:

  • Patients without competence for consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Faculty, Norwegian University of Science And Technology

Trondheim, 7441, Norway

RECRUITING

Related Publications (7)

  • 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.

    PMID: 20178636BACKGROUND

  • 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.

    PMID: 23557429BACKGROUND

  • 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.

    PMID: 25470096BACKGROUND

  • 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.

    PMID: 25219389BACKGROUND

  • 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.

    PMID: 29267990BACKGROUND

  • 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.

    PMID: 33287748DERIVED

  • 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.

    PMID: 30198055DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Gunnar Morken, PhD MD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arne Vaaler, PhD MD

CONTACT

+47 92090415arne.e.vaaler@ntnu.no

Gunnar Morken, PhD MD

CONTACT

+47 72823034gunnar.morken@ntnu.no

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 20, 2005

Study Start

January 1, 2003

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

December 12, 2025

Record last verified: 2025-12

Locations

NO(1)