Electroconvulsive Therapy (ECT) for Elderly Patients With Major Depression
ECT (electroconvulsive therapy) is mostly given to patients between the age of 60 - 85 years. There is limited evidence on the efficacy and cognitive side-effects of right unilateral (RU) and bifrontal (BF) electrode positions, the placements that are considered safe for the elderly. As far as the investigators know no randomized controlled trials (RCTs) have yet been published describing this population treated with BF or RU ECT. Non-demented depressed patients will be randomized to either method (n = 2x36). Symptom intensity, cognitive function and biomarkers will be related to 20 healthy comparators. Cognitive testing, evaluation of depression and blood-tests are done before ECT-treatment, after a series of 6-16 ECT and 3 months after terminated ECT-treatment.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Controlled Comparison of Bifrontal and Right Unilateral ECT as to Effects on Depression, Cognition and Biomarkers.|
- Depression [ Time Frame: 5 months ] [ Designated as safety issue: No ]Hamilton depression Scale 17 items (HAM-D-17), Montgomery Åsberg Depression Rating Scale (MADRS)
- Cognitive function [ Time Frame: 5 months ] [ Designated as safety issue: No ]MMSE, Vocabulary subtest - WASI and ten tests of anterograde and retrograde memory and executive function.
- Blood-tests [ Time Frame: 5 months ] [ Designated as safety issue: No ]Cytokines, complement factors, BDNF, S-100-beta among others
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Bifrontal ECT (BF)
Formula-based low dose BF ECT
Bifrontal ECT, low dosage
Experimental: Right unilateral ECT (RU)
Formula-based high-dose RU ECT
Right unilateral electrode position, high dosage
The cognitive test battery consists of ten tests of primarily memory and executive function. There is also a weekly rating of depression depth during the series. After the 6th ECT; Mini Mental Status Examination For a subgroup of patients; extensive blood-test samples are taken on the day of the 6th ECT.
Some of the patients receive continuation-ECT once monthly after the series. In these months patients receive treatment as usual (naturalistic observation).
The study of cognitive effects of ECT is funded from The Norwegian ExtraFoundation for Health & Rehabilitation.
|Contact: Tor Magne Bjølseth, MDfirstname.lastname@example.org|
|Contact: Torfinn Lødøen Gaarden, MDemail@example.com|
|Diakonhjemmet Hospital, Department of Old Age Psychiatry||Recruiting|
|Oslo, Norway, 0854|
|Principal Investigator: Tor Magne Bjølseth, MD|
|Principal Investigator: Torfinn Lødøen Gaarden, MD|
|Principal Investigator: Gro Strømnes Dybedal, Psychologist|
|Study Director:||Lars Tanum, Dr.Med.||University Hospital, Akershus|