Electroconvulsive Therapy (ECT) for Elderly Patients With Major Depression

Phase 4

Completed

• Conditions: Major Depression
• Interventions: Device: ECT

• Registration Number: NCT01559324
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-08
• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-21
• Primary Completion: 2013-07
• Study Completion: 2013-11
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-08
• Last Update Posted: 2015-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bifrontal ECT (BF)	ECT	Formula-based low dose BF ECT
Right unilateral ECT (RU)	ECT	Formula-based high-dose RU ECT

Primary Outcome Measures

Name	Time	Method
Depression	5 months	Hamilton depression Scale 17 items (HAM-D-17), Montgomery Åsberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

Name	Time	Method
Cognitive function	5 months
Blood-tests	5 months	Cytokines, complement factors, BDNF, S-100-beta among others

Trial Locations

Locations (1)

Diakonhjemmet Hospital, Department of Old Age Psychiatry; 🇳🇴 Oslo, Norway