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

This study has been completed.
Sponsor:
Information provided by:
The Alfred
ClinicalTrials.gov Identifier:
NCT00168376
First received: September 14, 2005
Last updated: April 13, 2007
Last verified: April 2007

September 14, 2005
April 13, 2007
July 2004
Not Provided
The outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). This is administered at baseline and on a fortnightly basis.
Same as current
Complete list of historical versions of study NCT00168376 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
A Randomised Double-Blind Trial of Targeted Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder
A Randomised Double-Blind Trial of Targeted Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder

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).

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
Major Depressive Disorder
Device: Transcranial Magnetic Stimulation
Not Provided
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. Epub 2009 Jan 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2006
Not Provided

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00168376
57/04
Not Provided
Not Provided
The Alfred
Not Provided
Principal Investigator: Paul B Fitzgerald, MBBS, PhD Alfred Psychiatry Research Centre
The Alfred
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP