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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168376
• Other study ID #: 57/04
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: April 13, 2007
• Start date: July 2004
• Est. completion date: April 2006

Study information

• Verified date: April 2007
• Source: The Alfred
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Transcranial Magnetic Stimulation

Locations

Country	Name	City	State
Australia	Alfred Psychiatry Research Centre	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
The Alfred

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). This is administered at baseline and on a fortnightly basis.
Secondary	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).