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CompletedNCT00168376Updated Apr 16, 2007

A Randomised Double-Blind Trial of Targeted Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder

An interventional study of Transcranial Magnetic Stimulation in Major Depressive Disorder, sponsored by The Alfred. Completed at 1 site in Australia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2007-04-16.

Sponsored by The Alfred · Not applicable, Interventional, and Educational/counseling/training

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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).
Read the detailed description

The outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). This is administered at baseline and on a fortnightly basis. At study end response criteria is defined as a 50% reduction in total MADRS score and remission defined as a MADRS score of less than or equal to 10.

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). A cognitive battery is also administered.

Inclusion Criteria:

  • 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 Exclusion Criteria
  • 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
02

Conditions studied

  • Major Depressive Disorder

Keywords

  • Transcranial Magnetic Stimulation
  • Depression
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 60 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

The Alfred is the lead sponsor of 45 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Educational/counseling/training
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
60 participants

Interventions

  • DeviceTranscranial Magnetic Stimulation
06

What researchers measure

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).

07

Study locations

1 site
  • Alfred Psychiatry Research Centre
    Melbourne, Victoria 3181, Australia
08

References and documents

Publications

  • 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. PubMed 19145228 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00168376
Lead sponsor
The Alfred
First posted
Sep 15, 2005
Start date
Jul 2004
Completion
Apr 2006
Last update
Apr 16, 2007

Study contacts

Paul B Fitzgerald, MBBS, PhD
principal investigator · Alfred Psychiatry Research Centre
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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