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

Sponsor

University of Erlangen-Nürnberg Medical School (Other)

Overall Status

Completed

CT.gov ID

NCT00370058

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder, Major	Procedure: ECT treatment	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

Homocysteine serum levels []

Secondary Outcome Measures

Cognitive functioning (e.g. concentration, memory tasks, etc.) []
Depressive symptomatology []
Measures of Seizure quality (duration, threshold, postictal suppression index, ...) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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