Priming rTMS In Major Depression

This study has been completed.
Sponsor:
Information provided by:
The Alfred
ClinicalTrials.gov Identifier:
NCT00168272
First received: September 14, 2005
Last updated: April 13, 2007
Last verified: April 2007
  Purpose

The purpose of this study is to assist in understanding the most effective parameters for TMS in Depressive Disorders. Most research conducted has used high frequency stimulation on the left hemisphere.However, low frequency on the right hemisphere has also been shown to have antidepressant properties and appears to be better tolerated. A promising approach to improve responses to rTMS may be to combine high and low frequency stimulation where they are both applied to the right side of the brain. In this approach, high frequency stimulation is provided first which may 'prime' or pre-prepare the brain for low frequency stimulation in a way that enhances its response. Participants are randomised to receive active or placebo priming stimulation.If participants do not respond to this treatment condition after 10 sessions applied over a two week period they will be offered 10 session of high frequency left sided TMS treatment. Alternatively, if participants respond favorably they may continue with that treatment condition for another 10 sessions.


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: Treatment
Official Title: A Randomised Double-Blind Trial of Low and High Frequency Stimulation rTMS (Repetitive Transcranial Magnetic Stimulation) In Major Depression

Resource links provided by NLM:


Further study details as provided by The Alfred:

Primary Outcome Measures:
  • The primary outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). At study end response criteria is defined as a 50% reduction in total MADRS score and remission defined as less or equal to 10.

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: 100
Study Start Date: June 2004
Study Completion Date: March 2007
Detailed Description:

The primary 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 electro-convulsive 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 electro-convulsive 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168272

Locations
Australia, Victoria
Alfred Psychiatry Research Centre
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
The Alfred
Investigators
Principal Investigator: Paul B Fitzgerald, MBBS, PhD Alfred Psychiatry Research Centre
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00168272     History of Changes
Other Study ID Numbers: 5/04
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:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014