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

NCT ID: NCT00069407

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Depression

Keywords

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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RUL

Right unilateral electroconvulsive therapy

Group Type ACTIVE_COMPARATOR

Electroconvulsive Therapy

Intervention Type PROCEDURE

Electroconvulsive therapy

BL

Bilateral electroconvulsive therapy

Group Type ACTIVE_COMPARATOR

Electroconvulsive Therapy

Intervention Type PROCEDURE

Electroconvulsive therapy

BF

Bifrontal electroconvulsive therapy

Group Type ACTIVE_COMPARATOR

Electroconvulsive Therapy

Intervention Type PROCEDURE

Electroconvulsive therapy

Interventions

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Electroconvulsive Therapy

Electroconvulsive therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of unipolar or bipolar depression
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles H Kellner, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

UMDNJ

Newark, New Jersey, United States

Site Status

Northshore/Long Island Jewish Hillside Hospital

Glen Oaks, New York, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 20194546 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19895623 (View on PubMed)

Other Identifiers

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R01MH067201

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR 83-ATSO

Identifier Type: -

Identifier Source: secondary_id

R01MH067201

Identifier Type: NIH

Identifier Source: org_study_id

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