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

• Status: Withdrawn
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sheppard Pratt Health System
• Collaborator: Central Michigan University
• Treatments: Antidepressive Agents

Criteria

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