Major Depressive Disorder
Conditions
Keywords
Transcranial Magnetic Stimulation, Depression
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
Interventions
DEVICETranscranial Magnetic Stimulation
Sponsors
The Alfred
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
ECT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The outcome measure used is the MADRS (Montgomery-Asberg Depression Rating Scale). This is administered at baseline and on a fortnightly basis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Australia
Outcome results
None listed