Transcranial Magnetic Stimulation for Bipolar Depression

March 29, 2023 updated by: Colleen Loo, The University of New South Wales

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia
        • Black Dog Research Institute
      • Sydney, New South Wales, Australia
        • Northside Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham
Device: Transcranial Magnetic Stimulation
Experimental: TMS
Device: Transcranial Magnetic Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
weekly
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: Weekly
Weekly
Clinical Global Impressions Scale (CGI)
Time Frame: Weekly
Weekly

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Global Improvement scale
Time Frame: Weekly
Weekly
Young Mania Rating Scale
Time Frame: weekly
weekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 7, 2007

First Submitted That Met QC Criteria

May 7, 2007

First Posted (Estimate)

May 8, 2007

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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