NCT00069407

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Feb 2003

Longer than P75 for not_applicable depression

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2003

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

December 16, 2014

Status Verified

December 1, 2014

Enrollment Period

3.2 years

First QC Date

September 24, 2003

Last Update Submit

December 12, 2014

Conditions

Depression

Keywords

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating Scale, 24 item

    Depression symptom rating

    4 weeks

Secondary Outcomes (1)

  • Neuropsychological assessment

    4 weeks

Study Arms (3)

RUL

ACTIVE COMPARATOR

Right unilateral electroconvulsive therapy

Procedure: Electroconvulsive Therapy

BL

ACTIVE COMPARATOR

Bilateral electroconvulsive therapy

Procedure: Electroconvulsive Therapy

BF

ACTIVE COMPARATOR

Bifrontal electroconvulsive therapy

Procedure: Electroconvulsive Therapy

Interventions

Electroconvulsive TherapyPROCEDURE

Electroconvulsive therapy

BFBLRUL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of unipolar or bipolar depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

UMDNJ

Newark, New Jersey, 07103, United States

Location

Northshore/Long Island Jewish Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Related Publications (2)

  • 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.

    PMID: 20194546DERIVED

  • 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.

    PMID: 19895623DERIVED

MeSH Terms

Conditions

DepressionBipolar Disorder

Interventions

Electroconvulsive Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorBipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Convulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Charles H Kellner, MD

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2003

First Posted

September 25, 2003

Study Start

February 1, 2003

Primary Completion

May 1, 2006

Study Completion

December 1, 2006

Last Updated

December 16, 2014

Record last verified: 2014-12

Locations

US(4)