A Randomised Double-Blind Trial of Targeted Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder
1 other identifier
interventional
60
1 country
1
Brief Summary
The study will involve a 3-week (15 session) randomized double-blind clinical trial of two repetitive transcranial magnetic stimulation (rTMS) conditions in patients with treatment resistant depression. rTMS site selection will be localized from structural MRI scans. The patients will be randomized to one of two conditions
- 1.rTMS targeted to the border of Brodmann area 46 and Brodmann area 9,
- 2.rTMS targeted to premotor cortex (this condition will act as the non-dorsolateral prefrontal cortex targeted control).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable major-depressive-disorder
Started Jul 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedApril 16, 2007
April 1, 2007
September 14, 2005
April 13, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). This is administered at baseline and on a fortnightly basis.
Secondary Outcomes (1)
Other outcome measures administered fortnightly are: BPRS (Brief Psychiatric Rating Scale), CORE (measure of melancholic symptoms), BDI (Beck Depression Inventory), CGI (Clinical Global Impression Scale), GAF (Global Assessment of Functioning Scale).
Interventions
Eligibility Criteria
You may qualify if:
- Moderate to severe depressive symptoms as indicated as MADRS \>20
- Failure to respond to a minimum of two antidepressant medications
- No increase or initiation of new antidepressant therapy in the four weeks prior to entering the trial
You may not qualify if:
- Have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating
- Previous brain injury or surgery, any metal clips, plates or other metal items in the head, cardiac pacemaker
- In the opinion of the investigator, are a sufficient suicide risk to require immediate electroconvulsive therapy
- Have a current DSMIV diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder or another axis 1 disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Alfredlead
Study Sites (1)
Alfred Psychiatry Research Centre
Melbourne, Victoria, 3181, Australia
Related Publications (1)
Fitzgerald PB, Hoy K, McQueen S, Maller JJ, Herring S, Segrave R, Bailey M, Been G, Kulkarni J, Daskalakis ZJ. A randomized trial of rTMS targeted with MRI based neuro-navigation in treatment-resistant depression. Neuropsychopharmacology. 2009 Apr;34(5):1255-62. doi: 10.1038/npp.2008.233. Epub 2009 Jan 14.
PMID: 19145228DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul B Fitzgerald, MBBS, PhD
Alfred Psychiatry Research Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- ECT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 15, 2005
Study Start
July 1, 2004
Study Completion
April 1, 2006
Last Updated
April 16, 2007
Record last verified: 2007-04