Transcranial Magnetic Stimulation in Bipolar Depression (TMS)

St. Joseph's Healthcare Hamilton

Status and phase: Completed; Phase 4

Conditions: Bipolar Affective Disorder

Treatments: Device: Transcranial Magnetic Stimulation (TMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT00186758

TMS2092

Details and patient eligibility

About

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)

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Bipolar Depression
• no physical health problems

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

1, Phase l, True or Sham

Sham Comparator group

Description:

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

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)

2, phase ll, Sham or True

Active Comparator group

Description:

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

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)