Study on the Influence of Electroconvulsive Therapy (ECT) on Homocysteine Levels
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00370058|
Recruitment Status : Completed
First Posted : August 30, 2006
Last Update Posted : July 11, 2008
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|
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Modulation of Homocysteine-Plasma Levels by ECT - Association With Clinical Response. A Pilot Study in Patients With Major Depression|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||August 2007|
- Homocysteine serum levels
- Cognitive functioning (e.g. concentration, memory tasks, etc.)
- Depressive symptomatology
- Measures of Seizure quality (duration, threshold, postictal suppression index, ...)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370058
|Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg|
|Erlangen, Germany, 91054|
|Principal Investigator:||Stefan Bleich, M.D.||University Erlangen-Nuremberg|
|Study Director:||Wolfgang Sperling, M.D.||University of Erlangen-Nürnberg|