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BMC Psychiatry
Published in: BMC Psychiatry 1/2010

Open Access 01-12-2010 | Study protocol

The study protocol of the Norwegian randomized controlled trial of electroconvulsive therapy in treatment resistant depression in bipolar disorder

Authors: Ute Kessler, Arne E Vaaler, Helle Schøyen, Ketil J Oedegaard, Per Bergsholm, Ole A Andreassen, Ulrik F Malt, Gunnar Morken

Published in: BMC Psychiatry | Issue 1/2010

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Abstract

Background

The treatment of depressive phases of bipolar disorder is challenging. The effects of the commonly used antidepressants in bipolar depression are questionable. Electroconvulsive therapy is generally considered to be the most effective treatment even if there are no randomized controlled trials of electroconvulsive therapy in bipolar depression. The safety of electroconvulsive therapy is well documented, but there are some controversies as to the cognitive side effects. The aim of this study is to compare the effects and side effects of electroconvulsive therapy to pharmacological treatment in treatment resistant bipolar depression. Cognitive changes and quality of life during the treatment will be assessed.

Methods/Design

A prospective, randomised controlled, multi-centre six- week acute treatment trial with seven clinical assessments. Follow up visit at 26 weeks or until remission (max 52 weeks). A neuropsychological test battery designed to be sensitive to changes in cognitive function will be used. Setting: Nine study centres across Norway, all acute psychiatric departments. Sample: n = 132 patients, aged 18 and over, who fulfil criteria for treatment resistant depression in bipolar disorder, Montgomery Åsberg Depression Rating Scale Score of at least 25 at baseline. Intervention: Intervention group: 3 sessions per week for up to 6 weeks, total up to 18 sessions. Control group: algorithm-based pharmacological treatment as usual.

Discussion

This study is the first randomized controlled trial that aims to investigate whether electroconvulsive therapy is better than pharmacological treatment as usual in treatment resistant bipolar depression. Possible long lasting cognitive side effects will be evaluated. The study is investigator initiated, without support from industry.

Trial registration

NCT00664976
Appendix
Available only for authorised users
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Metadata
Title
The study protocol of the Norwegian randomized controlled trial of electroconvulsive therapy in treatment resistant depression in bipolar disorder
Authors
Ute Kessler
Arne E Vaaler
Helle Schøyen
Ketil J Oedegaard
Per Bergsholm
Ole A Andreassen
Ulrik F Malt
Gunnar Morken
Publication date
01-12-2010
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2010
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/1471-244X-10-16

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