NCT01559324

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

July 9, 2015

Status Verified

July 1, 2015

Enrollment Period

3.9 years

First QC Date

March 19, 2012

Last Update Submit

July 8, 2015

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

  • Depression

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

    5 months

Secondary Outcomes (2)

  • Cognitive function

    5 months

  • Blood-tests

    5 months

Study Arms (2)

Bifrontal ECT (BF)

EXPERIMENTAL

Formula-based low dose BF ECT

Device: ECT

Right unilateral ECT (RU)

EXPERIMENTAL

Formula-based high-dose RU ECT

Device: ECT

Interventions

ECTDEVICE

Bifrontal ECT, low dosage

Bifrontal ECT (BF)

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diakonhjemmet Hospital, Department of Old Age Psychiatry

Oslo, 0854, Norway

Location

Related Publications (7)

  • 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.

    PMID: 14533122BACKGROUND

  • 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.

    PMID: 18311845BACKGROUND

  • 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.

    PMID: 18379338BACKGROUND

  • 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.

    PMID: 20562639BACKGROUND

  • 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.

    PMID: 20194546BACKGROUND

  • 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.

    PMID: 29940870DERIVED

  • 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.

    PMID: 25590761DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Lars Tanum, Dr.Med.

    University Hospital, Akershus

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.Student and Clinical Neuropsychologist

Study Record Dates

First Submitted

March 19, 2012

First Posted

March 21, 2012

Study Start

August 1, 2009

Primary Completion

July 1, 2013

Study Completion

November 1, 2013

Last Updated

July 9, 2015

Record last verified: 2015-07

Locations

NO(1)