Evaluation of Three Continuation Therapies After ECT Concerning Efficacy and Cognition in Severly Depressed Patients (EffECT)

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Eva-Lotta Brakemeier, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00437385
First received: February 20, 2007
Last updated: November 8, 2011
Last verified: November 2011
  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: TCAs, SSRIs, NARIs, SNRIs, Lithium
Procedure: Electroconvulsive therapy
Behavioral: Cognitive behavioral group therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1 Study: Evaluation of Three Continuation Therapies After Acute Electroconvusive Therapy (ECT) Concerning Efficacy and Cognition in Severly Depressed Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Score on HAMD after 6 and 12 months [ Time Frame: 6 and 12 months after enetering continuation phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relapse rate after 6 and 12 months [ Time Frame: 6 and 12 months after enetering continuation phase ] [ Designated as safety issue: No ]
  • Response and remission rates after 6 and 12 months [ Time Frame: 6 and 12 months after enetering continuation phase ] [ Designated as safety issue: No ]
  • Scores on MADRS, BDI, and CGI after 6 and 12 months [ Time Frame: 6 and 12 months after enetering continuation phase ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: March 2005
Study Completion Date: March 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Continuation-Medication with Antidepressants (after WBS Guidelines)
Drug: TCAs, SSRIs, NARIs, SNRIs, Lithium
Antidepressant, dosage, and duration are chosen due to the guidelines of the WFSBP (Bauer et al. 2002)
Experimental: 2
Continuation-ECT with Antidepressants
Drug: TCAs, SSRIs, NARIs, SNRIs, Lithium
Antidepressant, dosage, and duration are chosen due to the guidelines of the WFSBP (Bauer et al. 2002)
Procedure: Electroconvulsive therapy
ECT treatment is administered three times per week on non-successive weekdays and according to existing standards. Treatment lasts for at least three weeks (nine ECT sessions). Psychopharmacological treatment is continued during ECT treatment. Patients receive ultrabrief pulse (0.3 ms), unilateral treatment at a frequency of 40-100 Hertz. Stimulation is applied to the non-dominant hemisphere, according to the d'Elia electrode positioning paradigm. All patients are initially treated with right unilateral stimulation and in case of non-response switched to bilateral treatment. Stimulus intensity is chosen according to individual seizure threshold and administered at 2.5 to 6-fold intensity. During the ECT session, patients are anesthetized, under the influence of a muscle relaxant, and monitored regarding their vital functions.
Experimental: 3
Continuation-Psychotherapy (Cognitive Behavioral Group Psychotherapy including the "Situational Analysis" of CBASP)
Drug: TCAs, SSRIs, NARIs, SNRIs, Lithium
Antidepressant, dosage, and duration are chosen due to the guidelines of the WFSBP (Bauer et al. 2002)
Behavioral: Cognitive behavioral group therapy
The continuation-psychotherapy (continuation cognitive behavioral therapy, C-CBT) sample took part in a newly developed cognitive behavioral group therapy program called "EffECTive". This therapy program was developed within the EffECT-project (Brakemeier et al. 2005), to fit the specific target group of patients finished with acute ECT-treatment. EffECTive is a group therapy that combines several aspects of existing cognitive-behavioral depression manuals with new elements (e.g., the situational analysis from CBASP, McCullough 2000), to fit the target group. Therapy sessions were held once a week and include approximately 15 sessions until follow-up.

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
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: NCT00437385

Locations
Germany
Department of Psychiatry, Charité University Medicine, Campus Benjamin Franklin, Berlin, Germany
Berlin, Germany, 14050
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 and Psychotherapy, University Medicine, Freiburg, Germany
Study Chair: Norbert Kathmann, PhD Department of Clinical Psychology, Humboldt-University, Berlin, Germany
  More Information

Additional Information:
Publications:
Responsible Party: Eva-Lotta Brakemeier, Dr. rer. nat., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00437385     History of Changes
Other Study ID Numbers: ek224-05b
Study First Received: February 20, 2007
Last Updated: November 8, 2011
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on August 19, 2014