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. Identifier: NCT00370058
Recruitment Status : Completed
First Posted : August 30, 2006
Last Update Posted : July 11, 2008
Information provided by:
University of Erlangen-Nürnberg Medical School

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:


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
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 : August 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Homocysteine serum levels

Secondary Outcome Measures :
  1. Cognitive functioning (e.g. concentration, memory tasks, etc.)
  2. Depressive symptomatology
  3. Measures of Seizure quality (duration, threshold, postictal suppression index, ...)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00370058

Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg
Principal Investigator: Stefan Bleich, M.D. University Erlangen-Nuremberg
Study Director: Wolfgang Sperling, M.D. University of Erlangen-Nürnberg Identifier: NCT00370058     History of Changes
Other Study ID Numbers: ECT and Homocysteine
First Posted: August 30, 2006    Key Record Dates
Last Update Posted: July 11, 2008
Last Verified: December 2007

Keywords provided by University of Erlangen-Nürnberg Medical School:
mthfr genotype

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms