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

November 8, 2011 updated by: Eva-Lotta Brakemeier, Charite University, Berlin, Germany

Phase 1 Study: Evaluation of Three Continuation Therapies After Acute Electroconvusive Therapy (ECT) Concerning Efficacy and Cognition in Severly Depressed Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14050
        • Department of Psychiatry, Charité University Medicine, Campus Benjamin Franklin, Berlin, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score on HAMD after 6 and 12 months
Time Frame: 6 and 12 months after enetering continuation phase
6 and 12 months after enetering continuation phase

Secondary Outcome Measures

Outcome Measure
Time Frame
Relapse rate after 6 and 12 months
Time Frame: 6 and 12 months after enetering continuation phase
6 and 12 months after enetering continuation phase
Response and remission rates after 6 and 12 months
Time Frame: 6 and 12 months after enetering continuation phase
6 and 12 months after enetering continuation phase
Scores on MADRS, BDI, and CGI after 6 and 12 months
Time Frame: 6 and 12 months after enetering continuation phase
6 and 12 months after enetering continuation phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

February 20, 2007

First Submitted That Met QC Criteria

February 20, 2007

First Posted (ESTIMATE)

February 21, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 10, 2011

Last Update Submitted That Met QC Criteria

November 8, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ek224-05b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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