Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00168376
Status:
COMPLETED
Last Update Posted:
2007-04-16
First Post:
2005-09-14
Brief Title:
A Randomised Double-Blind Trial of Targeted Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder
Sponsor:
The Alfred
Organization:
The Alfred
Study Overview
Official Title:
A Randomised Double-Blind Trial of Targeted Repetitive Transcranial Magnetic Stimulation in Major Depressive Disorder
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 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
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
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 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