Transcranial Magnetic Stimulation for Bipolar Depression

This is a study to assess the effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a treatment for depressed adults with bipolar disorder.

Official Title

A Comparison of Left vs. Right Prefrontal Cortex Transcranial Magnetic Stimulation as a Treatment for Bipolar Depression

Conditions

Bipolar Depression

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Details

In rTMS high-intensity, fluctuating magnetic fields non-invasively stimulate the cortex of the brain depolarising neurons. No anaesthetic is required and the treatment in subconvulsive. Recent studies suggest that rTMS can be an effective treatment for depressive illness in adults (Loo and Mitchell et al, 2005) and appears to be quite safe.Most of the published studies to date have focused on unipolar depression. There is limited data of TMS use in bipolar depression. Eg. Pilot study by Nahas Z, Kozel FA, Li X, Anderson B, George MS.in 2003, which was negative.We wish to assess this in a sham-controlled study of adults. We hypothesise that both left and right sided rTMS will have an antidepressant effect superior to sham in this population. Primary Outcome Measures:

• All measures at baseline and at the end of each week of treatment in the blind phase and after every 2 weeks of treatment in the open phase. [Time Frame: weekly]
• Montgomery-Asberg Depression Rating Scale (MADRS) [Time Frame: Weekly]
• Clinical Global Impressions Scale (CGI) [Time Frame: Weekly]

Secondary Outcome Measures:

• Patient Global Improvement scale [Time Frame: Weekly]
• Young Mania Rating Scale [Time Frame: weekly]

Study Start

April 2007; Expected completion: April 2010

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 80 Years
• Genders Eligible for Study: Both

Inclusion Criteria:

• DSM-IV Major Depressive Episode of no more than 3 years.
• Diagnosis of bipolar I or II disorder
• Montgomery-Asberg Depression Rating Scale score of 20 or more.
• Aged over 18
• May or may not be taking antidepressant medication.

Exclusion Criteria:

• Patient not able to give informed consent.
• Failure to respond to ECT in current episode of depression.
• Significant other Axis I psychiatric disorders e.g. schizophrenia.
• In imminent physical or psychological danger, or needs rapid clinical response due to inanition, psychosis or high suicide risk.
• Comorbid substance abuse or dependence
• History of neurological illness e.g. epilepsy; neurosurgical procedure
• Metal in the cranium, a pacemaker, cochlear implant, medication pump or other electronic device.
• Women of child-bearing age in whom pregnancy cannot be ruled out.
• Patients with a history of mood ‘switching’ in response to other treatments.

Total Enrolment

100

Contact Details

Black Dog Research Institute, Sydney, New South Wales, Australia; Recruiting

• Melissa Pigot, BPsych(Hons): +61 2 9382 3720; m.pigot@unsw.edu.au

Northside Clinic, Sydney, New South Wales, Australia; Recruiting

• Melissa Pigot: 61-2-9382 3720; tms@unsw.edu.au