The study protocol of the Norwegian randomized controlled trial of electroconvulsive therapy in treatment resistant depression in bipolar disorder
Kessler, Ute; Vaaler, Arne E.; Schøyen, Helle; Ødegaard, Ketil Joachim; Bergsholm, Per; Andreassen, Ole Andreas; Malt, Ulrik Fredrik; Morken, Gunnar
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.