Transcranial Magnetic Stimulation for Bipolar Depression

This study has suspended participant recruitment.
(Poor recruitment)
Sponsor:
Information provided by:
The University of New South Wales
ClinicalTrials.gov Identifier:
NCT00470639
First received: May 7, 2007
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Bipolar Depression
Device: Transcranial Magnetic Stimulation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Comparison of Left vs. Right Prefrontal Cortex Transcranial Magnetic Stimulation as a Treatment for Bipolar Depression

Resource links provided by NLM:


Further study details as provided by The University of New South Wales:

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 ]

Estimated Enrollment: 100
Study Start Date: April 2007
Estimated Study Completion Date: April 2010
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470639

Locations
Australia, New South Wales
Black Dog Research Institute
Sydney, New South Wales, Australia
Northside Clinic
Sydney, New South Wales, Australia
Sponsors and Collaborators
The University of New South Wales
Investigators
Principal Investigator: Colleen Loo, FRANZCP, MD University of New South Wales
Study Director: William Lyndon, FRANZCP University of Sydney
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00470639     History of Changes
Other Study ID Numbers: 07103
Study First Received: May 7, 2007
Last Updated: September 25, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The University of New South Wales:
TMS
Treatment
Bipolar
Efficacy

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 28, 2014