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

Not Applicable

Completed

• Conditions: Depression
• Interventions: Procedure: Electroconvulsive Therapy

• Registration Number: NCT00069407
• Lead Sponsor: University of Medicine and Dentistry of New Jersey

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2003-09-24
• Study First Submitted QC: 2003-09-24
• Study First Posted: 2003-09-25
• Primary Completion: 2006-05
• Study Completion: 2006-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-12
• Last Update Posted: 2014-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Diagnosis of unipolar or bipolar depression

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RUL	Electroconvulsive Therapy	Right unilateral electroconvulsive therapy
BL	Electroconvulsive Therapy	Bilateral electroconvulsive therapy
BF	Electroconvulsive Therapy	Bifrontal electroconvulsive therapy

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale, 24 item	4 weeks	Depression symptom rating

Secondary Outcome Measures

Name	Time	Method
Neuropsychological assessment	4 weeks	neuropsychological test battery

Trial Locations

Locations (4)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Northshore/Long Island Jewish Hillside Hospital; 🇺🇸 Glen Oaks, New York, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

UMDNJ; 🇺🇸 Newark, New Jersey, United States