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

Not Applicable

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT00168376
• Lead Sponsor: The Alfred

Brief 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).

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

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-15
• Study Completion: 2006-04
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-13
• Last Update Posted: 2007-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Alfred Psychiatry Research Centre; 🇦🇺 Melbourne, Victoria, Australia