Electroconvulsive Therapy (ECT) for Elderly Patients With Major Depression

Study Overview
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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.

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).

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

Conditions
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Major Depression

Intervention / Treatment
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* Device: ECT
* Device: ECT


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bifrontal ECT (BF)<br>Formula-based low dose BF ECT | Device: ECT<br>* Bifrontal ECT, low dosage<br>|
| Experimental: Right unilateral ECT (RU)<br>Formula-based high-dose RU ECT | Device: ECT<br>* Right unilateral electrode position, high dosage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Hamilton depression Scale 17 items (HAM-D-17), Montgomery Åsberg Depression Rating Scale (MADRS) | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function |  | 5 months | 
| Blood-tests | Cytokines, complement factors, BDNF, S-100-beta among others | 5 months |