Transcranial Magnetic Stimulation in Bipolar Depression

Phase 4

Completed

• Conditions: Bipolar Affective Disorder
• Interventions: Device: Transcranial Magnetic Stimulation (TMS)

• Registration Number: NCT00186758
• Lead Sponsor: St. Joseph's Healthcare Hamilton

Brief Summary

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)

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.

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-02
• Last Update Posted: 2011-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Bipolar Depression
• no physical health problems

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1, Phase l, True or Sham	Transcranial Magnetic Stimulation (TMS)	this treatment will be True or Sham (placebo) on one side of the head, phase I
2, phase ll, Sham or True	Transcranial Magnetic Stimulation (TMS)	This treatment will be Sham(placebo)or True on the other side of the head phase II.

Primary Outcome Measures

Name	Time	Method
To compare antidepressant efficacy of right, left to sham	within 9 weeks

Secondary Outcome Measures

Name	Time	Method
To determine if QEEG activity correlates with antidepressant response to rTMS	within 9 weeks
To determine if non-responders can become responders if treating the opposite hemisphere	within 9 weeks

Trial Locations

Locations (1)

St. Joseph's Healthcare, rTMS Laboratory, Mood Disorder Program, 100 West Fifth Street; 🇨🇦 Hamilton, Ontario, Canada