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/NCT00920322




Registration number
NCT00920322
Ethics application status
Date submitted
11/06/2009
Date registered
15/06/2009
Date last updated
21/07/2011

Titles & IDs
Public title
Repetitive Transcranial Magnetic Stimulation (rTMS) in Depression
Scientific title
A Randomised Study of rTMS in Depression
Secondary ID [1] 0 0
UNSW HREC 9074
Secondary ID [2] 0 0
NSG HREC 153
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - rTMS 5 x weekly
Treatment: Devices - rTMS 3 times weekly

Active comparator: five times weekly - Patients will receive rTMS on each weekday for 4 weeks (5 x weekly)

Experimental: three times weekly - Patients will receive rTMS three times weekly for four weeks


Treatment: Devices: rTMS 5 x weekly
Patients will receive rTMS five times weekly for 4 weeks

Treatment: Devices: rTMS 3 times weekly
Patients will receive rTMS 3 times weekly for 4 weeks
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Depression Rating Scales
Timepoint [1] 0 0
weekly

Eligibility
Key inclusion criteria
* Aged >/= 18
* DSM-IV diagnosis of Major Depressive Episode (bipolar or MDD)
* MADRS score >/= 20
* Able to give informed consent
* Psychoactive medication dosages have been stable for a period of 4 weeks prior to entry in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Co-morbid alcohol or drug abuse or dependence (last 3 months), current eating disorder, mental retardation, schizophrenia, rapid cycling bipolar
* A history of mood 'switching' in response to other treatments, which cannot be contained by concurrent treatment, e.g., mood stabiliser
* Pregnancy
* Significant neurological disorder that increases seizure risk
* Metal objects in the head, pacemakers, or a history of epilepsy
* Patients who have failed to respond to a course of ECT in their current episode of depression
* A high risk of suicide

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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2011
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Northside Clinic - Greenwich
Recruitment postcode(s) [1] 0 0
2065 - Greenwich

Funding & Sponsors
Primary sponsor type
Other
Name
Northside Clinic, Australia
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, MBBS, FRANZCP, MD
Address 0 0
University of NSW
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/NCT00920322