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

Charité University Medicine Berlin

Status and phase: Completed; Phase 1

Conditions: Major Depression; Depression

Treatments: Procedure: Electroconvulsive therapy; Drug: TCAs, SSRIs, NARIs, SNRIs, Lithium; Behavioral: Cognitive behavioral group therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00437385

ek224-05b

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

1

Active Comparator group

Description:

Continuation-Medication with Antidepressants (after WBS Guidelines)

Treatment:

Drug: TCAs, SSRIs, NARIs, SNRIs, Lithium

2

Experimental group

Description:

Continuation-ECT with Antidepressants

Treatment:

Procedure: Electroconvulsive therapy

Drug: TCAs, SSRIs, NARIs, SNRIs, Lithium

3

Experimental group

Description:

Continuation-Psychotherapy (Cognitive Behavioral Group Psychotherapy including the "Situational Analysis" of CBASP)

Treatment:

Behavioral: Cognitive behavioral group therapy

Drug: TCAs, SSRIs, NARIs, SNRIs, Lithium