Transcranial Magnetic Stimulation for Bipolar Depression

Bipolar Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00470639
• Other study ID #: 07103
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: April 2007
• Est. completion date: December 2008

Study information

• Verified date: March 2023
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study to assess the effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a treatment for depressed adults with bipolar disorder. 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. The investigators wish to assess this in a sham-controlled study of adults. The investigators hypothesise that both left and right sided rTMS will have an antidepressant effect superior to sham in this population.

Description:

Inpatients and outpatients with major depressive episodes as part of either bipolar I or II illness will be eligible. In the event that patients (in any arm) have no significant response after a defined period, they will shift to an open phase where they will receive left prefrontal 10Hz stimulation. Thus all participants will have the opportunity to receive active treatment.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Device:
• Transcranial Magnetic Stimulation

Locations

Country	Name	City	State
Australia	Black Dog Research Institute	Sydney	New South Wales
Australia	Northside Clinic	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
The University of New South Wales

Country where clinical trial is conducted

Australia, 

References & Publications (2)

Loo CK, Mitchell PB. A review of the efficacy of transcranial magnetic stimulation (TMS) treatment for depression, and current and future strategies to optimize efficacy. J Affect Disord. 2005 Nov;88(3):255-67. doi: 10.1016/j.jad.2005.08.001. Epub 2005 Sep 2. — View Citation

Nahas Z, Kozel FA, Li X, Anderson B, George MS. Left prefrontal transcranial magnetic stimulation (TMS) treatment of depression in bipolar affective disorder: a pilot study of acute safety and efficacy. Bipolar Disord. 2003 Feb;5(1):40-7. doi: 10.1034/j.1399-5618.2003.00011.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		weekly
Primary	Montgomery-Asberg Depression Rating Scale (MADRS)		Weekly
Primary	Clinical Global Impressions Scale (CGI)		Weekly
Secondary	Patient Global Improvement scale		Weekly
Secondary	Young Mania Rating Scale		weekly