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Electroconvulsive Therapy (ECT) for Elderly Patients With Major Depression

Primary Purpose

Major Depression

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
ECT
ECT
Sponsored by
Diakonhjemmet Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Diakonhjemmet Hospital, Department of Old Age Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bifrontal ECT (BF)

Right unilateral ECT (RU)

Arm Description

Formula-based low dose BF ECT

Formula-based high-dose RU ECT

Outcomes

Primary Outcome Measures

Depression
Hamilton depression Scale 17 items (HAM-D-17), Montgomery Åsberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

Cognitive function
Blood-tests
Cytokines, complement factors, BDNF, S-100-beta among others

Full Information

First Posted
March 19, 2012
Last Updated
July 8, 2015
Sponsor
Diakonhjemmet Hospital
Collaborators
MD Tor Magne Bjølseth, MD Torfinn Lødøen Gaarden
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1. Study Identification

Unique Protocol Identification Number
NCT01559324
Brief Title
Electroconvulsive Therapy (ECT) for Elderly Patients With Major Depression
Official Title
Randomized Controlled Comparison of Bifrontal and Right Unilateral ECT as to Effects on Depression, Global Cognitive Function and Biomarkers.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diakonhjemmet Hospital
Collaborators
MD Tor Magne Bjølseth, MD Torfinn Lødøen Gaarden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bifrontal ECT (BF)
Arm Type
Experimental
Arm Description
Formula-based low dose BF ECT
Arm Title
Right unilateral ECT (RU)
Arm Type
Experimental
Arm Description
Formula-based high-dose RU ECT
Intervention Type
Device
Intervention Name(s)
ECT
Intervention Description
Bifrontal ECT, low dosage
Intervention Type
Device
Intervention Name(s)
ECT
Intervention Description
Right unilateral electrode position, high dosage
Primary Outcome Measure Information:
Title
Depression
Description
Hamilton depression Scale 17 items (HAM-D-17), Montgomery Åsberg Depression Rating Scale (MADRS)
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Cognitive function
Time Frame
5 months
Title
Blood-tests
Description
Cytokines, complement factors, BDNF, S-100-beta among others
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Tanum, Dr.Med.
Organizational Affiliation
University Hospital, Akershus
Official's Role
Study Director
Facility Information:
Facility Name
Diakonhjemmet Hospital, Department of Old Age Psychiatry
City
Oslo
ZIP/Postal Code
0854
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
14533122
Citation
van der Wurff FB, Stek ML, Hoogendijk WJ, Beekman AT. The efficacy and safety of ECT in depressed older adults: a literature review. Int J Geriatr Psychiatry. 2003 Oct;18(10):894-904. doi: 10.1002/gps.944.
Results Reference
background
PubMed Identifier
18311845
Citation
Tielkes CE, Comijs HC, Verwijk E, Stek ML. The effects of ECT on cognitive functioning in the elderly: a review. Int J Geriatr Psychiatry. 2008 Aug;23(8):789-95. doi: 10.1002/gps.1989.
Results Reference
background
PubMed Identifier
18379338
Citation
Gardner BK, O'Connor DW. A review of the cognitive effects of electroconvulsive therapy in older adults. J ECT. 2008 Mar;24(1):68-80. doi: 10.1097/YCT.0b013e318165c7b0.
Results Reference
background
PubMed Identifier
20562639
Citation
Kellner CH, Tobias KG, Wiegand J. Electrode placement in electroconvulsive therapy (ECT): A review of the literature. J ECT. 2010 Sep;26(3):175-80. doi: 10.1097/YCT.0b013e3181e48154.
Results Reference
background
PubMed Identifier
20194546
Citation
Kellner CH, Knapp R, Husain MM, Rasmussen K, Sampson S, Cullum M, McClintock SM, Tobias KG, Martino C, Mueller M, Bailine SH, Fink M, Petrides G. Bifrontal, bitemporal and right unilateral electrode placement in ECT: randomised trial. Br J Psychiatry. 2010 Mar;196(3):226-34. doi: 10.1192/bjp.bp.109.066183.
Results Reference
background
PubMed Identifier
29940870
Citation
Gaarden TL, Engedal K, Benth JS, Larsen M, Lorentzen B, Mollnes TE, Bjolseth TM, Castellheim A. Exploration of 27 plasma immune markers: a cross-sectional comparison of 64 old psychiatric inpatients having unipolar major depression and 18 non-depressed old persons. BMC Geriatr. 2018 Jun 25;18(1):149. doi: 10.1186/s12877-018-0836-x.
Results Reference
derived
PubMed Identifier
25590761
Citation
Bjolseth TM, Engedal K, Benth JS, Dybedal GS, Gaarden TL, Tanum L. Clinical efficacy of formula-based bifrontal versus right unilateral electroconvulsive therapy (ECT) in the treatment of major depression among elderly patients: a pragmatic, randomized, assessor-blinded, controlled trial. J Affect Disord. 2015 Apr 1;175:8-17. doi: 10.1016/j.jad.2014.12.054. Epub 2014 Dec 31.
Results Reference
derived

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Electroconvulsive Therapy (ECT) for Elderly Patients With Major Depression

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