Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00168272
Status:
COMPLETED
Last Update Posted:
2007-04-16
First Post:
2005-09-14
Brief Title:
Priming rTMS In Major Depression
Sponsor:
The Alfred
Organization:
The Alfred
Study Overview
Official Title:
A Randomised Double-Blind Trial of Low and High Frequency Stimulation rTMS Repetitive Transcranial Magnetic Stimulation In Major Depression
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 hemisphereHowever 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 stimulationIf 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None