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1. Major Depressive Disorder | Supplemental Transcranial Magnetic Stimulation (TMS) vs. Standard Medication Monotherapy for Treating Major Depression: An Exploratory Field Study

1. Major Depressive Disorder research study

What is the primary objective of this study?

A. Introduction to the Problem This field experiment is intended to explore whether supplemental transcranial magnetic stimulation (TMS) is more effective than standard medication mono-therapy for the treatment of major depressive disorder. Transcranial magnetic stimulation (TMS) is now included in the practice guidelines of the American Psychiatric Association for the treatment of major depression. B. Importance of the Area of Study The safety, efficacy and value of TMS treatment has been established through the four-phase FDA approval process. The evidence of TMS safety and efficacy derives from multiple, peer reviewed, double-blind, randomized, control trials (RCT) with sham control as well as strict enrollment and methodological requirements. TMS is now used in actual clinical practice and there is an opportunity to extend laboratory research and typical, highly controlled field settings to applied settings. This study is designed to gather data on safety, efficacy and utility of TMS as it is used in clinical practice. C. Need for Additional Research Efficacy and safety of these interventions have been scientifically established and meta-analyses of these studies underscore the efficacy and safety of two treatment interventions to be employed in this study: 1) standard medication monotherapy and 2) standard medication therapy supplemented with TMS. However, many authors conclude that depression can be difficult to treat and there is an ongoing need for additional research. Depression remains a major public health problem.

Who is eligible to participate?

Inclusion Criteria: 1. Determination of treatment resistance (i.e., failed to receive benefit from one to three prior anti-depressant treatments) 2. All subjects will be between the ages of 18 and 70 3. All subjects will meet the DSM-IV criteria for major depressive disorder, non-psychotic, single episode or recurrent, with a duration of episode of 3 years or less at the time of enrollment in the study. Exclusion Criteria: 1. A history or current existence of bi-polar disorder 2. A history or current existence of anxiety disorder 3. A history or current existence of mania 4. A history or current existence of psychosis 5. A history of continuous major depressive disorder for three years 6. A history or current existence of a significant medical co-morbidity 7. A history or current existence of a significant mental co-morbidity 8. A history of more than three standard medication trials with a less than adequate response

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

1. Major Depressive Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Supplemental TMSSupplemental TMS treatments will be administered utilizing the NeuroStar TMS Therapy® Machine. 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.

Drug:Standard Medication MonotherapyThese 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).

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Standard Medication Monotherapy GroupA group of 15 patients will receive only standard antidepressant medication treatment.

Supplemental TMS plus Medication GroupA group of 15 patients will receive supplemental transcranial magnetic stimulation (TMS) plus standard antidepressant medication.

Study Status

Withdrawn

Start Date: September 2013

Completed Date: December 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Montgomery-├ůsberg Depression Rating Scale (MADRS)

Secondary Outcome: Hamilton Rating Scale for Depression (HRSD)

Study sponsors, principal investigator, and references

Principal Investigator: Scott T Aaronson, MD

Lead Sponsor: Sheppard Pratt Health System

Collaborator: Central Michigan University

More information:https://clinicaltrials.gov/show/NCT01944657

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