Transcranial Magnetic Stimulation in Bipolar Depression

NCT ID: NCT00186758

Last Updated: 2011-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2011-07-31

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.

Conditions

Bipolar Affective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1, Phase l, True or Sham

this treatment will be True or Sham (placebo) on one side of the head, phase I

Group Type: SHAM_COMPARATOR

Transcranial Magnetic Stimulation (TMS)

Intervention Type: DEVICE

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 -

2, phase ll, Sham or True

This treatment will be Sham(placebo)or True on the other side of the head phase II.

Group Type: ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation (TMS)

Intervention Type: DEVICE

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 -

Interventions

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 -

Intervention Type: DEVICE

Other Intervention Names

HamD; BDI II; VAS

Eligibility Criteria

Inclusion Criteria

• Bipolar Depression
• no physical health problems

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University, Kingston, Ontario

OTHER

Sponsor Role: collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

McMaster University

Principal Investigators

Gary Hasey, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

St. Joseph's Healthcare, rTMS Laboratory, Mood Disorder Program, 100 West Fifth Street

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

TMS2092

Identifier Type: -

Identifier Source: org_study_id