Study on the Influence of Electroconvulsive Therapy (ECT) on Homocysteine Levels

Study Overview
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Brief Summary
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Elevated homocysteine levels are associated with depression and cognitive impairment. When depression ameliorates due to treatment, homocysteine serum levels often normalize. Aim of the present study is to investigate, whether repeated ECT treatment leads to changes in homocysteine levels and if these changes are associated with the occurrence of cognitive impairment after ECS. 10 patients suffering from therapy-resistant depression shall be enrolled. Patients are treated with repeated ECT (three times the week). Before, directly after and one day after ECT treatment, blood samples are drawn and patients receive cognitive testing. Depressive symptomatology is checked with different rating scales.

Detailed Description
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BACKGROUND: Elevated homocysteine levels have been found in depressive disorders. The modulating effects of homocysteine on glutamatergic neurotransmission have been discussed to be an underlying cause of depression and can also lead to cognitive impairment and may facilitate seizures. Electroconvulsive therapy is the most effective treatment for depression, but often leads to cognitive impairments. HYPOTHESIS: Homocysteine levels normalize during rECT. This normalization is associated with the clinical improvement of depression. Short term changes in homocysteine levels (i.e. increase directly after ECT) may explain the cognitive impairments of the patients. METHOD: 10 patients with therapy-resistant depressive disorder are to be enrolled into the trial. Patients are treated with rECT, two to three times a week. Blood withdrawal and psychometric analysis will be performed before, directly after and one day after ECT treatment 1,4,7,10,(13). Necessity of further treatment will be checked after the first 6 ECTs.

Official Title
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Modulation of Homocysteine-Plasma Levels by ECT - Association With Clinical Response. A Pilot Study in Patients With Major Depression

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Procedure: ECT treatment


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Men and women aged 18 years or above Diagnosis of major depressive disorder (according to DSM IV) Secured therapy resistance (at least two trials with antidepressive medication of different classes for more then 4 weeks in adequate dosage) Written, informed consent Key Exclusion Criteria: Major neurological or other diseases Current medication with antiepileptic drugs History of major head trauma Any medical condition not allowing anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: ECT treatment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homocysteine serum levels |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive functioning (e.g. concentration, memory tasks, etc.) |  |  | 
| Depressive symptomatology |  |  | 
| Measures of Seizure quality (duration, threshold, postictal suppression index, ...) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ect, homocysteine, depression, mthfr genotype