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P01-49 - The Study Protocol of the Norwegian Randomized Controlled Trial of Electroconvulsive Therapy in Treatment Resistant Depression in Bipolar Disorder

Published online by Cambridge University Press:  17 April 2020

U. Kessler ,
H. Schøyen ,
A. Vaaler ,
K. Ødegaard ,
P. Bergsholm ,
O.A. Andreassen ,
U. Malt  and
G. Morken
U. Kessler
Affiliation:
MoodNet Research Group, Haukeland University Hospital, Bergen, Norway
H. Schøyen
Affiliation:
MoodNet Research Group, University Hospital Stavanger, Stavanger, Norway
A. Vaaler
Affiliation:
Haukeland University Hospital, Bergen, Norway
K. Ødegaard
Affiliation:
MoodNet Research Group, Haukeland University Hospital, Bergen, Norway
P. Bergsholm
Affiliation:
MoodNet Research Group, Psychiatric Clinic Førde, Førde, Norway
O.A. Andreassen
Affiliation:
Division of Psychiatry, Oslo University Hospital, Ullevål, Norway Inst of Psychiatry, University of Oslo, Norway
U. Malt
Affiliation:
Inst of Psychiatry, University of Oslo, Norway Oslo University Hospital, Rikshospitalet, Oslo, Norway
G. Morken
Affiliation:
Østmarka Psychiatric Department, St. Olav University Hospital, Trondheim, Norway

Abstract

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Introduction

The treatment of depressive phases of bipolar disorder is challenging. Electroconvulsive therapy (ECT) is generally considered to be the most effective treatment even if there are no randomized controlled trials (RCT) of ECT in bipolar depression. The safety of ECT is well documented, but there are some controversies as to the cognitive side effects.

Objectives

To compare the effects and side effects of ECT with pharmacological treatment in treatment resistant bipolar depression. Cognitive changes during the treatment will be measured, as well as quality of life.

Method

A prospective, randomised controlled multi-centre trial. 6- week acute treatment trial with 7 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 wards

Sample

132 patients aged 18 and over, who fulfil criteria for treatment resistant depression in bipolar disorder, MADRS 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.

Results

Six departments have included 43 patients since start in May 2008.

Conclusion

This study is the first randomized controlled trial that aims to investigate whether ECT 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.

Type
Affective disorders / Unipolar depression / Bipolar disorder
Information
European Psychiatry , Volume 25 , Issue S1: 18th European Congress of Psychiatry. February 27, March 2, 2010 - Munich, Germany , 2010 , 25-E268
Copyright
Copyright © European Psychiatric Association 2010
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