Electroconvulsive Therapy (ECT) for Elderly Patients With Major Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Major Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bifrontal ECT (BF)

Formula-based low dose BF ECT

Group Type EXPERIMENTAL

ECT

Intervention Type DEVICE

Bifrontal ECT, low dosage

Right unilateral ECT (RU)

Formula-based high-dose RU ECT

Group Type EXPERIMENTAL

ECT

Intervention Type DEVICE

Right unilateral electrode position, high dosage

Interventions

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ECT

Bifrontal ECT, low dosage

Intervention Type DEVICE

ECT

Right unilateral electrode position, high dosage

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No