Transcranial Magnetic Stimulation in Bipolar Depression

Bipolar Affective Disorder Clinical Trial

— TMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186758
• Other study ID #: TMS2092
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: August 2, 2011
• Start date: July 2002
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Bipolar Depression

• no physical health problems

Exclusion Criteria:

• Metal in head/neck or skull

• History of Epilepsy

• Pregnancy

• Pacemaker

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Affective Disorder
• Bipolar Disorder
• Genetic Diseases, X-Linked
• Mood Disorders

Intervention

Device:
• Transcranial Magnetic Stimulation (TMS)
Phase l clients receive either True or Sham TMS treatments on left or right side of head for 10 days. Phase ll clients will receive either Sham or True TMS treatments on the other side of the head - the same type as in phase l -

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare, rTMS Laboratory, Mood Disorder Program, 100 West Fifth Street	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	Queen's University, Kingston, Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare antidepressant efficacy of right, left to sham		within 9 weeks	No
Secondary	To determine if QEEG activity correlates with antidepressant response to rTMS		within 9 weeks	No
Secondary	To determine if non-responders can become responders if treating the opposite hemisphere		within 9 weeks	No