Priming rTMS In Major Depression

April 13, 2007 updated by: The Alfred

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Psychiatry Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Alfred

Investigators

  • Principal Investigator: Paul B Fitzgerald, MBBS, PhD, Alfred Psychiatry Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

April 16, 2007

Last Update Submitted That Met QC Criteria

April 13, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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