Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00437385
Status:
COMPLETED
Last Update Posted:
2011-11-10
First Post:
2007-02-20
Brief Title:
Evaluation of Three Continuation Therapies After ECT Concerning Efficacy and Cognition in Severly Depressed Patients
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Phase 1 Study Evaluation of Three Continuation Therapies After Acute Electroconvusive Therapy ECT Concerning Efficacy and Cognition in Severly Depressed Patients
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EffECT
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None