Electroconvulsive Therapy (ECT) for Elderly Patients With Major Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01559324
Recruitment Status : Completed
First Posted : March 21, 2012
Last Update Posted : July 9, 2015
MD Tor Magne Bjølseth
MD Torfinn Lødøen Gaarden
Information provided by (Responsible Party):
Gro Strømnes Dybedal, Diakonhjemmet Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Major Depression Device: ECT Phase 4

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : August 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Depression [ Time Frame: 5 months ]
    Hamilton depression Scale 17 items (HAM-D-17), Montgomery Åsberg Depression Rating Scale (MADRS)

Secondary Outcome Measures :
  1. Cognitive function [ Time Frame: 5 months ]
  2. Blood-tests [ Time Frame: 5 months ]
    Cytokines, complement factors, BDNF, S-100-beta among others

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT01559324

Diakonhjemmet Hospital, Department of Old Age Psychiatry
Oslo, Norway, 0854
Sponsors and Collaborators
Diakonhjemmet Hospital
MD Tor Magne Bjølseth
MD Torfinn Lødøen Gaarden
Study Director: Lars Tanum, Dr.Med. University Hospital, Akershus

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gro Strømnes Dybedal, Ph.D.Student and Clinical Neuropsychologist, Diakonhjemmet Hospital Identifier: NCT01559324     History of Changes
Other Study ID Numbers: 6.2009.06 2011/02/0009
First Posted: March 21, 2012    Key Record Dates
Last Update Posted: July 9, 2015
Last Verified: July 2015

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