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


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