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Sponsors and Collaborators: |
Charite University, Berlin, Germany German Research Foundation |
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Information provided by: | Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT00437385 |
The purpose of this study is to evaluate three different continuation treatments after acute ECT concerning efficacy and impact on cognition in severly depressed patients.
Condition | Intervention | Phase |
---|---|---|
Depression Major Depression |
Drug: Antidepressants Procedure: Electroconvulsive therapy Behavioral: Cognitive behavioral group therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 1 Study: Evaluation of Three Continuation Therapies After Acute Electroconvusive Therapy (ECT) Concerning Efficacy and Cognition in Severly Depressed Patients |
Estimated Enrollment: | 60 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | November 2007 |
BACKGROUND While electroconvulsive therapy (ECT) in major depression is effective, high relapse rates and cognitive effects limit its long-term use. Continuation treatment after ECT with combinations of C-ECT or psychotherapy and medication may decrease relapse rates and cognitive side effects while changing cognitive psychological variables like dysfunctional attitudes in the long-term.
CENTRAL RESEARCH QUESTIONS
METHODS In a prospective, randomized, controlled, long-term study we assign 60 depressed ECT responder either to antidepressant treatment alone, or C-ECT plus medication, or cognitive behavioral group therapy plus medication. Depressive symptoms and cognition were assessed before, during, immediately after acute ECT and two, four, six, and 12 months during continuation therapy.
HYPOTHESES It is hypothesized that the use of combination continuation therapies after effective ECT leads to lower HAMD scores and lower relapse rates than the standard treatment with antidepressants alone after 6 months. In addition, we assume that the CBT group will establish more functional macro-patterns than the somatic treatments in the long term and will have the lowest HAMD scores and relapse rates after 1 year. With regard to the cognitive side effects, the autobiographical memory is expected to be the only specific part of memory being affected negatively by ECT in the short and long term.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eva-Lotta Brakemeier, MA | +49 178 8159707 | eva-lotta.brakemeier@charite.de |
Contact: Malek Bajbouj, PhD | +49 30 84458622 | malek.bajbouj@charite.de |
Germany | |
Department of Psychiatry, Charité University Medicine, Campus Benjamin Franklin, Berlin, Germany | Recruiting |
Berlin, Germany, 14050 | |
Contact: Eva-Lotta Brakemeier, MA +49 178 8159707 eva-lotta.brakemeier@charite.de | |
Contact: Arnim Quante, MD +49 30 8445 8730 arnim.quante@charite.de | |
Sub-Investigator: Arnim Quante, MD |
Study Chair: | Malek Bajbouj, PhD | Department of Psychiatry, Charité University Medicine, Campus Benjamin Franklin, Berlin, Germany |
Principal Investigator: | Eva-Lotta Brakemeier, MA | Department of Psychiatry, Charité University Medicine, Campus Benjamin Franklin, Berlin, Germany |
Study Chair: | Norbert Kathmann, PhD | Department of Clinical Psychology, Humboldt-University, Berlin, Germany |
Study ID Numbers: | ek224-05b |
Study First Received: | February 20, 2007 |
Last Updated: | February 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00437385 History of Changes |
Health Authority: | Germany: Ethics Commission |
therapy resistant depression, severe depression |
Depression Mental Disorders Psychotropic Drugs Mood Disorders |
Depressive Disorder, Major Depressive Disorder Antidepressive Agents Behavioral Symptoms |
Depression Mental Disorders Therapeutic Uses Psychotropic Drugs Mood Disorders Depressive Disorder, Major |
Depressive Disorder Central Nervous System Agents Pharmacologic Actions Antidepressive Agents Behavioral Symptoms |