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

This study has been completed.
Sponsor:
Information provided by:
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00370058
First received: August 29, 2006
Last updated: July 9, 2008
Last verified: December 2007
  Purpose

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 Intervention Phase
Depressive Disorder, Major
Procedure: ECT treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by University of Erlangen-Nürnberg Medical School:

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, ...)

Enrollment: 10
Study Start Date: August 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370058

Locations
Germany
Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg
Investigators
Principal Investigator: Stefan Bleich, M.D. University Erlangen-Nuremberg
Study Director: Wolfgang Sperling, M.D. University of Erlangen-Nuremberg
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00370058     History of Changes
Other Study ID Numbers: ECT and Homocysteine, Homocystein, ECT
Study First Received: August 29, 2006
Last Updated: July 9, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on October 01, 2014