Comparison of Three Electroconvulsive Therapy (ECT) Techniques for the Treatment of Major Depression
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electroconvulsive Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Bipolar Disorder
Eligibility Criteria
Inclusion Criteria: Diagnosis of unipolar or bipolar depression
Sites / Locations
- Mayo Clinic
- UMDNJ
- Northshore/Long Island Jewish Hillside Hospital
- University of Texas Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
RUL
BL
BF
Arm Description
Right unilateral electroconvulsive therapy
Bilateral electroconvulsive therapy
Bifrontal electroconvulsive therapy
Outcomes
Primary Outcome Measures
Hamilton Depression Rating Scale, 24 item
Depression symptom rating
Secondary Outcome Measures
Neuropsychological assessment
neuropsychological test battery
Full Information
NCT ID
NCT00069407
First Posted
September 24, 2003
Last Updated
December 12, 2014
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00069407
Brief Title
Comparison of Three Electroconvulsive Therapy (ECT) Techniques for the Treatment of Major Depression
Official Title
Comparing Three Electrode Placements to Optimize ECT
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RUL
Arm Type
Active Comparator
Arm Description
Right unilateral electroconvulsive therapy
Arm Title
BL
Arm Type
Active Comparator
Arm Description
Bilateral electroconvulsive therapy
Arm Title
BF
Arm Type
Active Comparator
Arm Description
Bifrontal electroconvulsive therapy
Intervention Type
Procedure
Intervention Name(s)
Electroconvulsive Therapy
Intervention Description
Electroconvulsive therapy
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale, 24 item
Description
Depression symptom rating
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Neuropsychological assessment
Description
neuropsychological test battery
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of unipolar or bipolar depression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles H Kellner, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
UMDNJ
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Northshore/Long Island Jewish Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20194546
Citation
Kellner CH, Knapp R, Husain MM, Rasmussen K, Sampson S, Cullum M, McClintock SM, Tobias KG, Martino C, Mueller M, Bailine SH, Fink M, Petrides G. Bifrontal, bitemporal and right unilateral electrode placement in ECT: randomised trial. Br J Psychiatry. 2010 Mar;196(3):226-34. doi: 10.1192/bjp.bp.109.066183.
Results Reference
derived
PubMed Identifier
19895623
Citation
Bailine S, Fink M, Knapp R, Petrides G, Husain MM, Rasmussen K, Sampson S, Mueller M, McClintock SM, Tobias KG, Kellner CH. Electroconvulsive therapy is equally effective in unipolar and bipolar depression. Acta Psychiatr Scand. 2010 Jun;121(6):431-6. doi: 10.1111/j.1600-0447.2009.01493.x. Epub 2009 Nov 8.
Results Reference
derived
Learn more about this trial
Comparison of Three Electroconvulsive Therapy (ECT) Techniques for the Treatment of Major Depression
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