Transcranial Magnetic Stimulation in Bipolar Depression - Full Text View

Purpose

To compare antidepressant efficacy of left or right to sham Repetitive Transcranial Magnetic Stimulation (rTMS)

to determine if non-responders can become responders if treated on the other side of the hemisphere

(rTMS)

Condition	Intervention	Phase
Bipolar Affective Disorder, Depressive Phase	Procedure: Transcranial Magnetic Stimulation (TMS)	Phase IV

MedlinePlus related topics:

Antidepressants Bipolar Disorder Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Official Title:	A Randomized, Sham Controlled, Crossover Trial of rTMS for Bipolar Depression

Further study details as provided by St. Joseph's Healthcare:

Primary Outcome Measures:

To compare antidepressant efficacy of right, left to sham

Secondary Outcome Measures:

To determine if QEEG activity correlates with antidepressant response to rTMS
To determine if non-responders can become responders if treating the opposite hemisphere

Estimated Enrollment:	40
Study Start Date:	June 2002

Detailed Description:

Patients will be assigned to one of 3 treatment arms for 10 days of treatment with either left high frequency or right high frequency, or sham rTMS. After 10 days of treatment, and no improvement, another 10 days of treatment follows, this time with the coil placed on the other hemisphere. Subjects will be followed for 2 months respectively with unrestricted treatment provided by their regular physician. Mood stabilizers will be continued throughout this trial.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Bipolar Depression
no physical health problems

Exclusion Criteria:

Metal in head/neck or skull
History of Epilepsy
Pregnancy
Pacemaker

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186758

Contacts


Contact: Rose Marie Mueller, RN	905-522-1155 ext 6629	rmueller@stjosham.on.ca

Contact: Gary Hasey, MD	905-522-1155 ext 5444	ghasey@sympatico.ca

Locations


Canada, Ontario
	St. Joseph's Healthcare, rTMS Laboratory, Mood Disorder Program, 100 West Fifth Street	Recruiting
	Hamilton, Ontario, Canada, L8N 3K7
	Contact: Rose Marie Mueller, RN 905-522-1155 ext 6629 rmueller@stjosham.on.ca
	Contact: jackie Heaslip, RN 905-522-1155 ext 5484 jheaslip@stjosham.on.ca

Sponsors and Collaborators

St. Joseph's Healthcare

Queen's University, Kingston, Ontario

Investigators


Principal Investigator:	Gary Hasey, MD	McMaster University

More Information

Study ID Numbers:	TMS2092
First Received:	September 13, 2005
Last Updated:	October 26, 2005
ClinicalTrials.gov Identifier:	NCT00186758
Health Authority:	Canada: Health Canada

Keywords provided by St. Joseph's Healthcare:

Transcranilal Magnetic Stimulation

TMS

Study placed in the following topic categories:

Affective Disorders, Psychotic

Depression

Mental Disorders

Bipolar Disorder

Mood Disorders

Psychotic Disorders

Depressive Disorder

Behavioral Symptoms

ClinicalTrials.gov processed this record on October 24, 2008

Sponsors and Collaborators:	St. Joseph's Healthcare Queen's University, Kingston, Ontario
Information provided by:	St. Joseph's Healthcare
ClinicalTrials.gov Identifier:	NCT00186758