Electroconvulsive Therapy (ECT) for Elderly Patients With Major Depression

Diakonhjemmet Hospital

Status and phase: Completed; Phase 4

Conditions: Major Depression

Treatments: Device: ECT

Study type: Interventional

Funder types: Other

Identifiers

NCT01559324

6.2009.06 2011/02/0009

Details and patient eligibility

About

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.

Full 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).

Enrollment: 92 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups

Bifrontal ECT (BF)

Experimental group

Description:

Formula-based low dose BF ECT

Treatment:

Device: ECT

Device: ECT

Right unilateral ECT (RU)

Experimental group

Description:

Formula-based high-dose RU ECT

Treatment:

Device: ECT

Device: ECT