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Evaluation of Three Continuation Therapies After ECT Concerning Efficacy and Cognition in Severly Depressed Patients (EffECT)
This study is currently recruiting participants.
Verified by Charite University, Berlin, Germany, February 2007
First Received: February 20, 2007   No Changes Posted
Sponsors and Collaborators: Charite University, Berlin, Germany
German Research Foundation
Information provided by: Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00437385
  Purpose

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

MedlinePlus related topics: Antidepressants Depression
U.S. FDA Resources
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

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Score on HAMD after 6 and 12 months

Secondary Outcome Measures:
  • Relapse rate after 6 and 12 months
  • Response and remission rates after 6 and 12 months
  • Scores on MADRS, BDI, and CGI after 6 and 12 months

Estimated Enrollment: 60
Study Start Date: March 2005
Estimated Study Completion Date: November 2007
Detailed Description:

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

  • Evaluation of the efficacy of three continuation treatments aimed at preventing relapses after acute ECT
  • Examination of the cognitive side effects and the changes of cognitive psychological variables during acute and continuation treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major depressive episode (unipolar)
  • Response to acute ECT (at least 50% reduction in HAMD)
  • Capacity to consent
  • Sufficient comprehension of the German language

Exclusion Criteria:

  • Schizophrenia, schizoaffective disorder, or other psychosis
  • Amnestic disorder, dementia, or delirium
  • Pregnancy
  • Epilepsy
  • Current alcohol or substance abuse or dependence
  • CNS disease or brain injury not associated with psychotropic drug exposure
  • ECT in the past 3 months
  • Acute suicidality
  • Judiciary hospitalization
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437385

Contacts
Contact: Eva-Lotta Brakemeier, MA +49 178 8159707 eva-lotta.brakemeier@charite.de
Contact: Malek Bajbouj, PhD +49 30 84458622 malek.bajbouj@charite.de

Locations
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            
Sponsors and Collaborators
Charite University, Berlin, Germany
German Research Foundation
Investigators
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
  More Information

Additional Information:
Publications:
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

Keywords provided by Charite University, Berlin, Germany:
therapy resistant depression, severe depression

Study placed in the following topic categories:
Depression
Mental Disorders
Psychotropic Drugs
Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Antidepressive Agents
Behavioral Symptoms

Additional relevant MeSH terms:
Depression
Mental Disorders
Therapeutic Uses
Psychotropic Drugs
Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 07, 2009