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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00069407
First Posted: September 25, 2003
Last Update Posted: December 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
  Purpose
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.

Condition Intervention
Depression Procedure: Electroconvulsive Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Three Electrode Placements to Optimize ECT

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):

Primary Outcome Measures:
  • Hamilton Depression Rating Scale, 24 item [ Time Frame: 4 weeks ]
    Depression symptom rating


Secondary Outcome Measures:
  • Neuropsychological assessment [ Time Frame: 4 weeks ]
    neuropsychological test battery


Enrollment: 230
Study Start Date: February 2003
Study Completion Date: December 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of unipolar or bipolar depression
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00069407


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Jersey
UMDNJ
Newark, New Jersey, United States, 07103
United States, New York
Northshore/Long Island Jewish Hillside Hospital
Glen Oaks, New York, United States, 11004
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Charles H Kellner, MD Rutgers, The State University of New Jersey
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier: NCT00069407     History of Changes
Other Study ID Numbers: R01MH067201 ( U.S. NIH Grant/Contract )
DSIR 83-ATSO
First Submitted: September 24, 2003
First Posted: September 25, 2003
Last Update Posted: December 16, 2014
Last Verified: December 2014

Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):
Bipolar Disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders