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

Phase 1

Completed

• Conditions: Major Depression; Depression
• Interventions: Drug: TCAs, SSRIs, NARIs, SNRIs, Lithium; Procedure: Electroconvulsive therapy; Behavioral: Cognitive behavioral group therapy

• Registration Number: NCT00437385
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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.

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 Timeline

• Study Start: 2005-03
• Study First Submitted: 2007-02-20
• Study First Submitted QC: 2007-02-20
• Study First Posted: 2007-02-21
• Primary Completion: 2010-03
• Study Completion: 2011-03
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-08
• Last Update Posted: 2011-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	TCAs, SSRIs, NARIs, SNRIs, Lithium	Continuation-Medication with Antidepressants (after WBS Guidelines)
2	TCAs, SSRIs, NARIs, SNRIs, Lithium	Continuation-ECT with Antidepressants
2	Electroconvulsive therapy	Continuation-ECT with Antidepressants
3	TCAs, SSRIs, NARIs, SNRIs, Lithium	Continuation-Psychotherapy (Cognitive Behavioral Group Psychotherapy including the "Situational Analysis" of CBASP)
3	Cognitive behavioral group therapy	Continuation-Psychotherapy (Cognitive Behavioral Group Psychotherapy including the "Situational Analysis" of CBASP)

Primary Outcome Measures

Name	Time	Method
Score on HAMD after 6 and 12 months	6 and 12 months after enetering continuation phase

Secondary Outcome Measures

Name	Time	Method
Relapse rate after 6 and 12 months	6 and 12 months after enetering continuation phase
Response and remission rates after 6 and 12 months	6 and 12 months after enetering continuation phase
Scores on MADRS, BDI, and CGI after 6 and 12 months	6 and 12 months after enetering continuation phase

Trial Locations

Locations (1)

Department of Psychiatry, Charité University Medicine, Campus Benjamin Franklin, Berlin, Germany; 🇩🇪 Berlin, Germany