Electroconvulsive Therapy (ECT) for Elderly Patients With Major Depression

This study has been completed.
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: April 9, 2014
Last verified: April 2014
  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, global cognitive function and biomarkers will be related to 20 healthy comparators. 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, Global Cognitive Function and Biomarkers.

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

  • Blood-tests [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Cytokines, complement factors, BDNF, S-100-beta among others


Enrollment: 92
Study Start Date: August 2009
Study Completion Date: November 2013
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:

Patients are assessed with Mini Mental Status Examination. Postictal reorientation time is measured. 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).

  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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01559324

Locations
Norway
Diakonhjemmet Hospital, Department of Old Age Psychiatry
Oslo, Norway, 0854
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: April 9, 2014
Health Authority: Norway: Regional Ethics Commitee

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

ClinicalTrials.gov processed this record on October 23, 2014