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

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dc.contributor.author Kessler, Ute
dc.contributor.author Vaaler, Arne E.
dc.contributor.author Schøyen, Helle
dc.contributor.author Ødegaard, Ketil Joachim
dc.contributor.author Bergsholm, Per
dc.contributor.author Andreassen, Ole A.
dc.contributor.author Malt, Ulrik F.
dc.contributor.author Morken, Gunnar
dc.date.accessioned 2011-04-28T08:47:45Z
dc.date.available 2011-04-28T08:47:45Z
dc.date.issued 2010-02-23
dc.identifier.citation BMC Psychiatry 10:16 en_US
dc.identifier.issn 1471-244X
dc.identifier.uri http://dx.doi.org/10.1186/1471-244X-10-16
dc.identifier.uri http://hdl.handle.net/1956/4707
dc.description.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. en_US
dc.language.iso eng en_US
dc.publisher BioMed Central en
dc.rights Copyright 2010 Kessler et al; licensee BioMed Central Ltd. en_US
dc.rights.uri http://creativecommons.org/licenses/by/2.0 en_US
dc.title The study protocol of the Norwegian randomized controlled trial of electroconvulsive therapy in treatment resistant depression in bipolar disorder en_US
dc.type Peer reviewed en_US
dc.type Journal article en_US
dc.rightsHolder Kessler et al. en_US
dc.type.version publishedVersion en_US
bora.cristinID 349680


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Copyright 2010 Kessler et al; licensee BioMed Central Ltd. Except where otherwise noted, this item's license is described as Copyright 2010 Kessler et al; licensee BioMed Central Ltd.

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