NCT00470639

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

May 7, 2007

Last Update Submit

March 29, 2023

Conditions

Bipolar Depression

Keywords

TMSTreatmentBipolarEfficacy

Outcome Measures

Primary Outcomes (3)

  • 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

  • Montgomery-Asberg Depression Rating Scale (MADRS)

    Weekly

  • Clinical Global Impressions Scale (CGI)

    Weekly

Secondary Outcomes (2)

  • Patient Global Improvement scale

    Weekly

  • Young Mania Rating Scale

    weekly

Study Arms (2)

TMS

EXPERIMENTAL
Device: Transcranial Magnetic Stimulation

Sham

SHAM COMPARATOR
Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic StimulationDEVICE
ShamTMS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Black Dog Research Institute

Sydney, New South Wales, Australia

Location

Northside Clinic

Sydney, New South Wales, Australia

Location

Related Publications (2)

  • 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.

    PMID: 12656937BACKGROUND

  • 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.

    PMID: 16139895BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Colleen Loo, FRANZCP, MD

    University of New South Wales

    PRINCIPAL INVESTIGATOR

  • William Lyndon, FRANZCP

    University of Sydney

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 7, 2007

First Posted

May 8, 2007

Study Start

April 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 3, 2023

Record last verified: 2023-03

Locations

AU(2)