Changes in Cerebral Glucose Metabolism After Electroconvulsive Therapy (ECT)

Study Overview
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Brief Summary
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There exist already a few studies that have measured changes of brain metabolism pre and post Electroconvulsive Therapy (ECT) by Positron emission tomography (PET) but these were all performed in a small number of patients and used different methodologies. It is therefore not surprising that these investigations provided inconsistent results, as reviewed previously {{23 Schmidt,E.Z. 2008}}. In patients with treatment-refractory major depressive episodes, the investigators here therefore probed (a) whether changes in cerebral glucose metabolism measured by PET occur after treatment with ECT and (b) whether these correlate with the clinical amelioration of symptoms. To pursue this goal, the investigators assessed clinical effects, neurocognitive function, and brain metabolism using 18F-Fluoro-deoxyglucose (18F-FDG) PET at baseline and at the end of treatment. Patients with a treatment refractory depression - defined as absent clinical improvement of depressive symptoms after at least two trials with antidepressants from different pharmacologic classes adequate in dose, duration of at least 6 weeks, and compliance {{30 Berlim,M.T. 2007}} - in whom ECT had been intended on clinical grounds were consecutively asked for participation in this study. Patients had to be between 18 and 80 years old and to be physically healthy.

Official Title
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Clinical Effects of Electroconvulsive Therapy in Severe Depression and Concomitant Changes in Cerebral Glucose Metabolism - an Exploratory Study

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: Electroconvulsive therapy
* Device: 18-Fluoro-desoxy-glucose positron emission tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical indication for ECT treatment refractory depressive episode age 18-85 y Exclusion Criteria: addiction as a first diagnosis dementia

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECT verum group<br>Patients with treatment refractory depression treated with ECT | Device: Electroconvulsive therapy<br>* treatment for major depression<br>* Other names: no other names;Device: 18-Fluoro-desoxy-glucose positron emission tomography<br>* intravenous injection of 18-FDG, after 30 min PET-Scan of the brain for aprox. 40 min. It´s a neuroimaging technique.<br>* Other names: no other names;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain glucose metabolism measured by FDG-PET |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, FDG-PET, Electroconvulsive therapy, glucose metabolism