Electroconvulsive Therapy (ECT) for Elderly Patients With Major Depression

Major Depression Clinical Trial

Official title:

Randomized Controlled Comparison of Bifrontal and Right Unilateral ECT as to Effects on Depression, Global Cognitive Function and Biomarkers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559324
• Other study ID #: 6.2009.06 2011/02/0009
• Status: Completed
• Phase: Phase 4
• First received: March 19, 2012
• Last updated: July 8, 2015
• Start date: August 2009
• Est. completion date: November 2013

Study information

• Verified date: July 2015
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: November 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Device:
• ECT
Bifrontal ECT, low dosage
• ECT
Right unilateral electrode position, high dosage

Locations

Country	Name	City	State
Norway	Diakonhjemmet Hospital, Department of Old Age Psychiatry	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital	MD Tor Magne Bjølseth, MD Torfinn Lødøen Gaarden

Country where clinical trial is conducted

Norway, 

References & Publications (5)

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. Review. — View 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. — View 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. Review. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression	Hamilton depression Scale 17 items (HAM-D-17), Montgomery Åsberg Depression Rating Scale (MADRS)	5 months	No
Secondary	Cognitive function		5 months	No
Secondary	Blood-tests	Cytokines, complement factors, BDNF, S-100-beta among others	5 months	No