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

December 12, 2014 updated by: University of Medicine and Dentistry of New Jersey

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • UMDNJ
    • New York
      • Glen Oaks, New York, United States, 11004
        • Northshore/Long Island Jewish Hillside Hospital
    • Texas
      • Dallas, Texas, United States, 75235
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of unipolar or bipolar depression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RUL
Right unilateral electroconvulsive therapy
Procedure: Electroconvulsive Therapy
Electroconvulsive therapy
Active Comparator: BL
Bilateral electroconvulsive therapy
Procedure: Electroconvulsive Therapy
Electroconvulsive therapy
Active Comparator: BF
Bifrontal electroconvulsive therapy
Procedure: Electroconvulsive Therapy
Electroconvulsive therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Depression Rating Scale, 24 item
Time Frame: 4 weeks
Depression symptom rating
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychological assessment
Time Frame: 4 weeks
neuropsychological test battery
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Charles H Kellner, MD, Rutgers, The State University of New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 24, 2003

First Submitted That Met QC Criteria

September 24, 2003

First Posted (Estimate)

September 25, 2003

Study Record Updates

Last Update Posted (Estimate)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 12, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH067201 (U.S. NIH Grant/Contract)
  • DSIR 83-ATSO (National Institute of Mental Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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