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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Terminated
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
This study will report on the outcomes of rTMS administered 3 times per week, compared with
the standard protocol of 5 times per week. Participants will be randomly assigned to
frequency condition and depressive symptomatology will be measured weekly using a range of
clinician and self-rated questionnaires. Participants will remain in the study for at least 4
weeks, with the option of continuing for a further 2 weeks as judged by the study
psychiatrist. It is hypothesised that rTMS administered three times per week will be equally
as effective as rTMS administered five times per week in reducing depressive symptomatology.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00920322
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00920322