MedPath

NeuroStar TMS Therapy System: Utilization and Outcomes

Completed
Conditions
Major Depressive Disorder
Registration Number
NCT01114477
Lead Sponsor
Neuronetics
Brief Summary

The major objective of this observational study is to describe clinical outcomes of patients receiving treatment with the NeuroStar TMS Therapy system in routine clinical practice.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
307
Inclusion Criteria
  • Major Depressive Disorder
Exclusion Criteria
  • Contraindications to treatment with TMS

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Total Score on the Patient Health Questionnaire 9-Item (PHQ-9)Baseline and 6 weeks

The primary outcome measure will reported as the change from baseline through 6 weeks for the total score on the PHQ-9.

Secondary Outcome Measures
NameTimeMethod
Health Resource Utilization Questionnaire (HRU)Baseline, 6 weeks, and 12 Months

The change from baseline in health care service utilization reported on the individual questions contained in the HRU will be reported for the 6 week and 12 month time points.

Total score for the Clinical Global Impressions-Severity (CGI-S)Baseline, 6 weeks and 12 Months

The change from baseline to endpoint on the total score for the CGI-S will be reported for the 6 week and 12 month time points.

Total Score for the EuroQol Questionnaire (EQ-5D)Baseline, 6 weeks, and 12 Months.

The change from baseline to endpoint on the total score for the EQ-5D will be reported for the 6 week and 12 month time points.

Short Form 36-Item Questionnaire(SF-36) Individual Factor Scores and General Medical and Mental Health Composite ScoresBaseline, 6 weeks, and 12 Months.

The change from baseline to endpoint on the Individual Factor Scores and General Medical and Mental Health Composite Scores for the SF-36 will be reported for the 6 week and 12 month time points.

Total score for the Inventory of Depressive Symptoms-Self Report (IDS-SR)Baseline, 6 weeks and 12 Months

The change from baseline to endpoint on the total score for the IDS-SR will be reported for the 6 week and 12 month time points.

Trial Locations

Locations (44)

Lee Ann Kelley, M.D., PC

๐Ÿ‡บ๐Ÿ‡ธ

Phoenix, Arizona, United States

Sacramento TMS

๐Ÿ‡บ๐Ÿ‡ธ

El Dorado Hills, California, United States

Todd Hutton, MD & Associates

๐Ÿ‡บ๐Ÿ‡ธ

Pasadena, California, United States

Arjun Reyes, MD

๐Ÿ‡บ๐Ÿ‡ธ

Woodland Hills, California, United States

Behavioral Health Care Associates

๐Ÿ‡บ๐Ÿ‡ธ

Schaumburg, Illinois, United States

TMS Center of Beverly Hills

๐Ÿ‡บ๐Ÿ‡ธ

Beverly Hills, California, United States

Curtis Cassidy, MD

๐Ÿ‡บ๐Ÿ‡ธ

Lakeland, Florida, United States

Brain Stimulation Chicago North Shore

๐Ÿ‡บ๐Ÿ‡ธ

Northbrook, Illinois, United States

Butler Hospital

๐Ÿ‡บ๐Ÿ‡ธ

Providence, Rhode Island, United States

The Botkiss Center for TMS Therapy

๐Ÿ‡บ๐Ÿ‡ธ

San Diego, California, United States

Kevin Kinback, MD

๐Ÿ‡บ๐Ÿ‡ธ

Mission Viejo, California, United States

Stanford Hospital and Clinics

๐Ÿ‡บ๐Ÿ‡ธ

Stanford, California, United States

Christiana Care Health Services

๐Ÿ‡บ๐Ÿ‡ธ

Wilmington, Delaware, United States

Santa Fe TMS Therapy Center

๐Ÿ‡บ๐Ÿ‡ธ

Santa Fe, New Mexico, United States

Central Psychiatry

๐Ÿ‡บ๐Ÿ‡ธ

Las Vegas, Nevada, United States

Dent Neurosciences Research Center, Inc.

๐Ÿ‡บ๐Ÿ‡ธ

Amherst, New York, United States

Anthony Drobnick, MD

๐Ÿ‡บ๐Ÿ‡ธ

St. Michaels, Maryland, United States

Spectrum Behavioral Health

๐Ÿ‡บ๐Ÿ‡ธ

Annapolis, Maryland, United States

Health Sciences America, LLC

๐Ÿ‡บ๐Ÿ‡ธ

Boca Raton, Florida, United States

Brian Teliho, MD

๐Ÿ‡บ๐Ÿ‡ธ

Atlanta, Georgia, United States

Serenity Center for Depression, P.A.

๐Ÿ‡บ๐Ÿ‡ธ

Sugar Land, Texas, United States

Orange County TMS Center

๐Ÿ‡บ๐Ÿ‡ธ

Laguna Hills, California, United States

Hartford Hospital

๐Ÿ‡บ๐Ÿ‡ธ

Hartford, Connecticut, United States

Rush University Medical Center

๐Ÿ‡บ๐Ÿ‡ธ

Chicago, Illinois, United States

Carl M. Wahlstrom, Jr. MD Limited

๐Ÿ‡บ๐Ÿ‡ธ

Chicago, Illinois, United States

Sheppard Pratt Health System

๐Ÿ‡บ๐Ÿ‡ธ

Baltimore, Maryland, United States

Bay Psychiatric Associates

๐Ÿ‡บ๐Ÿ‡ธ

Berkeley, California, United States

Clinical Training & Research Institute

๐Ÿ‡บ๐Ÿ‡ธ

Burlingame, California, United States

Martha Koo, MD

๐Ÿ‡บ๐Ÿ‡ธ

Hermosa Beach, California, United States

Comprehensive Psychiatric Care

๐Ÿ‡บ๐Ÿ‡ธ

Norwich, Connecticut, United States

Integrative Psychiatry

๐Ÿ‡บ๐Ÿ‡ธ

Louisville, Kentucky, United States

Newton-Wellesley Psychiatry

๐Ÿ‡บ๐Ÿ‡ธ

Newton, Massachusetts, United States

TMS Center of New England

๐Ÿ‡บ๐Ÿ‡ธ

Portsmouth, New Hampshire, United States

W. Scott West, M.D.

๐Ÿ‡บ๐Ÿ‡ธ

Nashville, Tennessee, United States

Texas TMS Center at Senior Adults Specialty Healthcare (SASH)

๐Ÿ‡บ๐Ÿ‡ธ

Austin, Texas, United States

Houston TMS

๐Ÿ‡บ๐Ÿ‡ธ

Houston, Texas, United States

Depression Research Center and Clinic-Semel Institute for Neuroscience & Human Behavior at UCLA

๐Ÿ‡บ๐Ÿ‡ธ

Los Angeles, California, United States

University Psychiatric Foundation

๐Ÿ‡บ๐Ÿ‡ธ

Louisville, Kentucky, United States

Center for Anxiety and Depression

๐Ÿ‡บ๐Ÿ‡ธ

Mercer Island, Washington, United States

The TMS Institute of Pennsylvania-Advanced Neuropsychiatric Solutions

๐Ÿ‡บ๐Ÿ‡ธ

West Chester, Pennsylvania, United States

Northwestern Medical Faculty Foundation

๐Ÿ‡บ๐Ÿ‡ธ

Chicago, Illinois, United States

Agape Mind Services/The Costello Clinic

๐Ÿ‡บ๐Ÿ‡ธ

Lewisville, Texas, United States

University Neuropsychiatric Institute

๐Ÿ‡บ๐Ÿ‡ธ

Salt Lake City, Utah, United States

Texas Neuropsychiatric Institute

๐Ÿ‡บ๐Ÿ‡ธ

Amarillo, Texas, United States

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