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Transcranial Magnetic Stimulation for Bipolar Depression

Primary Purpose

Bipolar Depression

Status
Withdrawn
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sponsored by
The University of New South Wales
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Depression focused on measuring TMS, Treatment, Bipolar, Efficacy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Black Dog Research Institute
  • Northside Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

TMS

Sham

Arm Description

Outcomes

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.
Montgomery-Asberg Depression Rating Scale (MADRS)
Clinical Global Impressions Scale (CGI)

Secondary Outcome Measures

Patient Global Improvement scale
Young Mania Rating Scale

Full Information

First Posted
May 7, 2007
Last Updated
March 29, 2023
Sponsor
The University of New South Wales
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1. Study Identification

Unique Protocol Identification Number
NCT00470639
Brief Title
Transcranial Magnetic Stimulation for Bipolar Depression
Official Title
A Comparison of Left vs. Right Prefrontal Cortex Transcranial Magnetic Stimulation as a Treatment for Bipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Poor recruitment
Study Start Date
April 2007 (Actual)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of New South Wales

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
TMS, Treatment, Bipolar, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TMS
Arm Type
Experimental
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Primary Outcome Measure Information:
Title
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
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame
Weekly
Title
Clinical Global Impressions Scale (CGI)
Time Frame
Weekly
Secondary Outcome Measure Information:
Title
Patient Global Improvement scale
Time Frame
Weekly
Title
Young Mania Rating Scale
Time Frame
weekly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Loo, FRANZCP, MD
Organizational Affiliation
University of New South Wales
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Lyndon, FRANZCP
Organizational Affiliation
University of Sydney
Official's Role
Study Director
Facility Information:
Facility Name
Black Dog Research Institute
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Northside Clinic
City
Sydney
State/Province
New South Wales
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
12656937
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.
Results Reference
background
PubMed Identifier
16139895
Citation
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.
Results Reference
background

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Transcranial Magnetic Stimulation for Bipolar Depression

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