Treatment Resistant Depression in Bipolar Disorder - A Randomized Controlled Trial of Electroconvulsive Therapy
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|ClinicalTrials.gov Identifier: NCT00664976|
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : January 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Procedure: Electroconvulsive therapy Other: Treatment as usual||Not Applicable|
This project is a randomized controlled trial of electroconvulsive therapy (ECT) compared to treatment as usual (TAU) in the treatment of treatment resistant depression (TRD) in bipolar disorder. The purpose of the trial is to document the effect size, relative effect size and adverse effects of ECT in this condition. A specific purpose is to gain more knowledge about the effect on cognitive function.
In a national collaboration project the investigators will compare the antidepressant and cognitive effects of ECT with the effects of a drug treatment in use for this condition; a treatment algorithm combining antidepressants, mood stabilizer and antipsychotic drugs. The investigators will use a neuropsychological test battery to disclose possible ECT induced changes in cognitive function, and investigate any long-lasting changes.
In addition, several studies have implemented inflammatory processes in the pathogenesis of depression; inflammatory processes will be examined as a function of changes in clinical status and of treatment modality.
The study is a national collaboration, using the Bipolar Research And Innovation Network- BRAIN, and all the patients are included in the BRAIN-study. The study is funded by Helse Vest RHF, Regional research network on mood disorders (MoodNet) and Norwegian hospitals.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Treatment Resistant Depression in Bipolar Disorder - A Randomized Controlled Trial of Electroconvulsive Therapy|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||September 2013|
Procedure: Electroconvulsive therapy
Active Comparator: 2
Treatment as usual
Other: Treatment as usual
Pharmacological antidepressant as usual in the departments: Mood stabilizers as Lithium, lamotrigine, valproate, quetiapine, carbamazepine and olanzapine. Antidepressants + Psychosocial treatment as usual.
- Improvement in depression [ Time Frame: 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664976
|Haukeland University Hospital|
|Bergen, Norway, 5000|
|St Olavs Hospital, Østmarka sykehus|
|Study Director:||Arne Vaaler, MD PhD||NTNU; Helse Vest RHF|