Comparison of Three Electroconvulsive Therapy (ECT) Techniques for the Treatment of Major Depression

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00069407
First received: September 24, 2003
Last updated: January 16, 2008
Last verified: January 2008

September 24, 2003
January 16, 2008
February 2003
May 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00069407 on ClinicalTrials.gov Archive Site
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Comparison of Three Electroconvulsive Therapy (ECT) Techniques for the Treatment of Major Depression
Comparing Three Electrode Placements to Optimize ECT

This study will compare the antidepressant benefits and cognitive side effects of three different types of electroconvulsive therapy (ECT) in people with unipolar or bipolar depression.

ECT is an important treatment for severely depressed people who do not respond adequately to, or are intolerant of, antidepressant medication. Traditionally, ECT has been administered with one of two standard techniques: bilateral and right unilateral electrode placement. However, these techniques are limited by either low efficacy or high cognitive impairment. Recently, an additional technique for ECT administration has shown promise in preliminary studies: bifrontal ECT. This study will compare this technique to the two traditional ECT techniques in treating people with depressive symptoms.

Participants in this study will be randomly assigned to receive standard bilateral ECT, high-dose right unilateral ECT, or bifrontal ECT in their index course. Depression symptoms, neuropsychological status, and quality of life will be measured throughout the course of the ECT treatment, one week after, and at a 2-month follow-up visit. This study will run for 4 years.

Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Depression
Procedure: Electroconvulsive Therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
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May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of unipolar or bipolar depression
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00069407
R01 MH67201, DSIR 83-ATSO
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National Institute of Mental Health (NIMH)
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Not Provided
National Institute of Mental Health (NIMH)
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP