Transcranial Magnetic Stimulation for Bipolar Depression | NCT00470639

Studies
Transcranial Magnetic Stimulation for Bipolar Depression

NCT00470639

Sponsor

The University of New South Wales

Status

Withdrawn

Last Update Posted

Apr 3, 2023Actual

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Bipolar Depression

Interventions

Transcranial Magnetic Stimulation

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Poor recruitment

Expanded Access Info

Start Date

Apr 2007Actual

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

May 7, 2007

First Submission Date that Met QC Criteria

May 7, 2007

First Posted Date

May 8, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2023

Last Update Posted Date

Apr 3, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TMS	Experimental		Device: Transcranial Magnetic Stimulation
Sham	Sham Comparator		Device: Transcranial Magnetic Stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcranial Magnetic Stimulation	Device		Sham TMS

Outcomes Module

Primary Outcomes

Measure	Description	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.		weekly
Montgomery-Asberg Depression Rating Scale (MADRS)		Weekly
Clinical Global Impressions Scale (CGI)		Weekly

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Colleen Loo, FRANZCP, MD	University of New South Wales	Principal Investigator
William Lyndon, FRANZCP	University of Sydney	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Black Dog Research Institute		Sydney	New South Wales		Australia
Northside Clinic

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12656937	Background	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.
16139895	Background	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.

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D055909	Magnetic Field Therapy
D013812	Therapeutics