Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Experimental: TMS -

Sham comparator: Sham -

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
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00470639