Supplemental TMS vs. Standard Medication Monotherapy for Treating Major Depression: An Exploratory Field Study

Fifteen TMS treatment subjects will be selected from a patient population served in a free-standing psychiatric hospital program (i.e., Sheppard Pratt Health System). There are approximately 40 patients currently enrolled in the TMS program and this is the TMS sampling frame of reference. Fifteen standard medication therapy subjects will be selected from a patient population treated in a private, outpatient psychiatric practice in Northern Virginia. There are hundreds of outpatients being treated in this outpatient practice and this is the standard medication therapy sampling frame of reference.

The sample size will be adequate to achieve a 95% level of confidence with an acceptable margin of error. Consistent with stringent inclusion and exclusion criteria, it is anticipated that a fairly homogeneous and comparable study groupings can be identified. Again, due to the limited number of TMS patients eligible for enrollment in the study, a non-random, non-probability assignment or matching method will be used to make sure the study groups, based upon the demographics and clinical characteristics, are similar in the most important respects.

TMS treatments will be administered utilizing the NeuroStar TMS Therapy® Machine manufactured by Neuronetics, Inc. of Malvern, Pennsylvania. Treatment will be fixed at 120% of magnetic field intensity relative to the subject's resting motor threshold at a repetition rate of ten magnetic pulses per second, with a stimulus train duration (i.e., on time) of 4 seconds and an inter train interval (i.e., off time) of 26 seconds. The left dorsolateral prefrontal cortex will be the treatment location and this site will be determined by adjusting the TMS coil 5 cm anterior to the motor threshold location along a left superior oblique plane with a rotation point at about the tip of the patient's nose. Each treatment session will last approximately 37.5 minutes administering 3,000 magnetic pulses over the course of the treatment session. Repetitive TMS will be performed over the left dorsolateral prefrontal cortex. Each TMS subject received a minimum of thirty TMS treatments (i.e., ideally five treatments per week for six weeks) of 10 - Hz treatments (1,200 pulses per treatment day) at 90% of motor threshold.

The standard medication treatment group received only standard medication treatment for a period of eight weeks. As described in an earlier table, these medications could include bupropion (Wellbutrin and others), citalopram (Celexa and others), Clomipramine (Ananfranil and others), duloxetine (Cymbalta), escitalopram (Lexapro and others), fluoxetine (Prozac and others), fluvoxamine (Luvox and others), imipramine (Tofranil and others), mirtazapine (Remeron and others), nortriptylatine (Pamelor, Aventyl, and others), paroxetine (Paxil, Pexeva, and others), phenelzine (Nardil), sertraline (Zoloft and others), tranylcypromine (Parnate and others), venlafaxine (Effexor and others).

Consents and base line measures will be obtained. The TMS and standard medication therapy subjects will be selected from a patient population with at one to three less than adequate responses to standard medication therapy. One group (15 patients) will receive TMS as well as standard medication therapy and the other group (15 patients) will continue with their current medication.