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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00069407
First received: September 24, 2003
Last updated: December 12, 2014
Last verified: December 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Three Electrode Placements to Optimize ECT

Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale, 24 item [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Depression symptom rating


Secondary Outcome Measures:
  • Neuropsychological assessment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of unipolar or bipolar depression
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Charles H Kellner, MD Rutgers, The State University of New Jersey
  More Information

No publications provided by Rutgers, The State University of New Jersey

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00069407     History of Changes
Other Study ID Numbers: R01 MH67201, R01MH067201, DSIR 83-ATSO
Study First Received: September 24, 2003
Last Updated: December 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Rutgers, The State University of New Jersey:
Bipolar Disorder

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 26, 2015