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Electroconvulsive Therapy (ECT) for Elderly Patients With Major Depression

This study is currently recruiting participants.
Verified May 2013 by Diakonhjemmet Hospital
Sponsor:
Collaborators:
MD Tor Magne Bjølseth
MD Torfinn Lødøen Gaarden
Information provided by (Responsible Party):
Gro Strømnes Dybedal, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier:
NCT01559324
First received: March 19, 2012
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Major Depression
 Device: ECT
 Phase 4

Study Type: Interventional
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.

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Diakonhjemmet Hospital:

Primary Outcome Measures:
  • Depression [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Hamilton depression Scale 17 items (HAM-D-17), Montgomery Åsberg Depression Rating Scale (MADRS)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 92
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)
Arms Assigned Interventions
Experimental: Bifrontal ECT (BF)
Formula-based low dose BF ECT
 Device: ECT
Bifrontal ECT, low dosage
Experimental: Right unilateral ECT (RU)
Formula-based high-dose RU ECT
 Device: ECT
Right unilateral electrode position, high dosage

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major depression, either unipolar or bipolar.
  • Competent to give informed consent.
  • Passing a thorough physical examination

Exclusion Criteria:

  • Previous ECT non - response
  • ECT given during last 6 months
  • Ongoing substance abuse
  • Rapid cycling bipolar or schizoaffective disorder
  • Parkinsons disease
  • Cognitive impairment (MMSE < 24/30)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559324

Contacts
Contact: Tor Magne Bjølseth, MD +4722458500 tormagne1@live.no
Contact: Torfinn Lødøen Gaarden, MD +4722458500 torfgaa@online.no

Locations
Norway
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            
Sponsors and Collaborators
Diakonhjemmet Hospital
MD Tor Magne Bjølseth
MD Torfinn Lødøen Gaarden
Investigators
Study Director: Lars Tanum, Dr.Med. University Hospital, Akershus
  More Information

Publications:

Responsible Party: Gro Strømnes Dybedal, Ph.D.Student and Clinical Neuropsychologist, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT01559324     History of Changes
Other Study ID Numbers: 6.2009.06 2011/02/0009
Study First Received: March 19, 2012
Last Updated: May 23, 2013
Health Authority: Norway: Regional Ethics Commitee

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013