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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
History of Changes
  Purpose

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).

Condition Intervention
Major Depressive Disorder
 Device: Transcranial Magnetic Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
Official Title: A Randomised Double-Blind Trial of Targeted Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by The Alfred:

Primary Outcome Measures:
  • The outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). This is administered at baseline and on a fortnightly basis.

Secondary Outcome Measures:
  • 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).

Estimated Enrollment: 60
Study Start Date: July 2004
Study Completion Date: April 2006
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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00168376

Locations
Australia, Victoria
Alfred Psychiatry Research Centre
Melbourne, Victoria, Australia, 3181
Sponsors and Collaborators
The Alfred
Investigators
Principal Investigator: Paul B Fitzgerald, MBBS, PhD Alfred Psychiatry Research Centre
  More Information

No publications provided by The Alfred

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00168376     History of Changes
Other Study ID Numbers: 57/04
Study First Received: September 14, 2005
Last Updated: April 13, 2007
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The Alfred:
Transcranial Magnetic Stimulation
Depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 23, 2013