Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00470639




Registration number
NCT00470639
Ethics application status
Date submitted
7/05/2007
Date registered
8/05/2007
Date last updated
3/04/2023

Titles & IDs
Public title
Transcranial Magnetic Stimulation for Bipolar Depression
Scientific title
A Comparison of Left vs. Right Prefrontal Cortex Transcranial Magnetic Stimulation as a Treatment for Bipolar Depression
Secondary ID [1] 0 0
07103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Transcranial Magnetic Stimulation

Experimental: TMS -

Sham Comparator: Sham -


Treatment: Devices: Transcranial Magnetic Stimulation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
weekly
Primary outcome [2] 0 0
Montgomery-Asberg Depression Rating Scale (MADRS)
Timepoint [2] 0 0
Weekly
Primary outcome [3] 0 0
Clinical Global Impressions Scale (CGI)
Timepoint [3] 0 0
Weekly
Secondary outcome [1] 0 0
Patient Global Improvement scale
Timepoint [1] 0 0
Weekly
Secondary outcome [2] 0 0
Young Mania Rating Scale
Timepoint [2] 0 0
weekly

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Black Dog Research Institute - Sydney
Recruitment hospital [2] 0 0
Northside Clinic - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00470639
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Colleen Loo, FRANZCP, MD
Address 0 0
University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00470639