Clinical trial NCT00069407: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Bipolar Disorder
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-09-25
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of unipolar or bipolar depression

Primary outcomes:
measure: Hamilton Depression Rating Scale, 24 item
timeFrame: 4 weeks
Secondary outcomes:
measure: Neuropsychological assessment
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Newark
country: United States
facility: UMDNJ
state: New Jersey
city: Glen Oaks
country: United States
facility: Northshore/Long Island Jewish Hillside Hospital
state: New York
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Charles H Kellner, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.