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

NCT00437385 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2011-11-10

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER
  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Malek Bajbouj, PhD · Department of Psychiatry, Charité University Medicine, Campus Benjamin Franklin, Berlin, Germany

  • Eva-Lotta Brakemeier, MA · Department of Psychiatry and Psychotherapy, University Medicine, Freiburg, Germany

  • Norbert Kathmann, PhD · Department of Clinical Psychology, Humboldt-University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2010-03-31
Completion
2011-03-31

Countries

  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00437385 on ClinicalTrials.gov