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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

September 24, 2003
December 12, 2014
February 2003
May 2006   (final data collection date for primary outcome measure)
Hamilton Depression Rating Scale, 24 item [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Depression symptom rating
Not Provided
Complete list of historical versions of study NCT00069407 on ClinicalTrials.gov Archive Site
Neuropsychological assessment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
neuropsychological test battery
Not Provided
Not Provided
Not Provided
 
Comparison of Three Electroconvulsive Therapy (ECT) Techniques for the Treatment of Major Depression
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Depression
Procedure: Electroconvulsive Therapy
Electroconvulsive therapy
  • Active Comparator: RUL
    Right unilateral electroconvulsive therapy
    Intervention: Procedure: Electroconvulsive Therapy
  • Active Comparator: BL
    Bilateral electroconvulsive therapy
    Intervention: Procedure: Electroconvulsive Therapy
  • Active Comparator: BF
    Bifrontal electroconvulsive therapy
    Intervention: Procedure: Electroconvulsive Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
230
December 2006
May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of unipolar or bipolar depression
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00069407
R01 MH67201, R01MH067201, DSIR 83-ATSO
Yes
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
University of Medicine and Dentistry of New Jersey
National Institute of Mental Health (NIMH)
Principal Investigator: Charles H Kellner, MD Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP