Transcranial Magnetic Stimulation for Bipolar Depression

NCT ID: NCT00470639

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2008-12-31

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.

Conditions

Bipolar Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TMS

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Sham

Group Type: SHAM_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Interventions

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of New South Wales

OTHER

Sponsor Role: lead

Responsible Party

Colleen Loo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Colleen Loo, FRANZCP, MD

Role: PRINCIPAL_INVESTIGATOR

University of New South Wales

William Lyndon, FRANZCP

Role: STUDY_DIRECTOR

University of Sydney

Locations

Black Dog Research Institute

Sydney, New South Wales, Australia

Northside Clinic

Sydney, New South Wales, Australia

Countries

Australia

References

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.

Reference Type: BACKGROUND

PMID: 12656937 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16139895 (View on PubMed)

Other Identifiers

07103

Identifier Type: -

Identifier Source: org_study_id