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

Depression Clinical Trial

— EffECT  

Official title:

Phase 1 Study: Evaluation of Three Continuation Therapies After Acute Electroconvusive Therapy (ECT) Concerning Efficacy and Cognition in Severly Depressed Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00437385
• Other study ID #: ek224-05b
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2007
• Last updated: November 8, 2011
• Start date: March 2005
• Est. completion date: March 2011

Study information

• Verified date: November 2011
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Psychiatry, Charité University Medicine, Campus Benjamin Franklin, Berlin, Germany	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Research Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Kellner CH, Knapp RG, Petrides G, Rummans TA, Husain MM, Rasmussen K, Mueller M, Bernstein HJ, O'Connor K, Smith G, Biggs M, Bailine SH, Malur C, Yim E, McClintock S, Sampson S, Fink M. Continuation electroconvulsive therapy vs pharmacotherapy for relapse prevention in major depression: a multisite study from the Consortium for Research in Electroconvulsive Therapy (CORE). Arch Gen Psychiatry. 2006 Dec;63(12):1337-44. — View Citation

Lisanby SH, Maddox JH, Prudic J, Devanand DP, Sackeim HA. The effects of electroconvulsive therapy on memory of autobiographical and public events. Arch Gen Psychiatry. 2000 Jun;57(6):581-90. — View Citation

Sackeim HA, Haskett RF, Mulsant BH, Thase ME, Mann JJ, Pettinati HM, Greenberg RM, Crowe RR, Cooper TB, Prudic J. Continuation pharmacotherapy in the prevention of relapse following electroconvulsive therapy: a randomized controlled trial. JAMA. 2001 Mar 14;285(10):1299-307. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on HAMD after 6 and 12 months		6 and 12 months after enetering continuation phase	No
Secondary	Relapse rate after 6 and 12 months		6 and 12 months after enetering continuation phase	No
Secondary	Response and remission rates after 6 and 12 months		6 and 12 months after enetering continuation phase	No
Secondary	Scores on MADRS, BDI, and CGI after 6 and 12 months		6 and 12 months after enetering continuation phase	No