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

The Alfred

Status

Completed

Conditions

Major Depressive Disorder

Treatments

Device: Transcranial Magnetic Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT00168376

57/04

Details and patient eligibility

About

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

rTMS targeted to the border of Brodmann area 46 and Brodmann area 9,
rTMS targeted to premotor cortex (this condition will act as the non-dorsolateral prefrontal cortex targeted control).

Full 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

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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