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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT00437385

Collaborator

German Research Foundation (Other)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Major Depression	Drug: TCAs, SSRIs, NARIs, SNRIs, Lithium Procedure: Electroconvulsive therapy Behavioral: Cognitive behavioral group therapy	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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

Study Start Date :

Mar 1, 2005

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Score on HAMD after 6 and 12 months [6 and 12 months after enetering continuation phase]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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