NeuroStar TMS Therapy System: Utilization and Outcomes
- 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
- Major Depressive Disorder
- Contraindications to treatment with TMS
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Scores Baseline, 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
๐บ๐ธPhoenix, Arizona, United States
Sacramento TMS
๐บ๐ธEl Dorado Hills, California, United States
Todd Hutton, MD & Associates
๐บ๐ธPasadena, California, United States
Arjun Reyes, MD
๐บ๐ธWoodland Hills, California, United States
Behavioral Health Care Associates
๐บ๐ธSchaumburg, Illinois, United States
TMS Center of Beverly Hills
๐บ๐ธBeverly Hills, California, United States
Curtis Cassidy, MD
๐บ๐ธLakeland, Florida, United States
Brain Stimulation Chicago North Shore
๐บ๐ธNorthbrook, Illinois, United States
Butler Hospital
๐บ๐ธProvidence, Rhode Island, United States
The Botkiss Center for TMS Therapy
๐บ๐ธSan Diego, California, United States
Kevin Kinback, MD
๐บ๐ธMission Viejo, California, United States
Stanford Hospital and Clinics
๐บ๐ธStanford, California, United States
Christiana Care Health Services
๐บ๐ธWilmington, Delaware, United States
Santa Fe TMS Therapy Center
๐บ๐ธSanta Fe, New Mexico, United States
Central Psychiatry
๐บ๐ธLas Vegas, Nevada, United States
Dent Neurosciences Research Center, Inc.
๐บ๐ธAmherst, New York, United States
Anthony Drobnick, MD
๐บ๐ธSt. Michaels, Maryland, United States
Spectrum Behavioral Health
๐บ๐ธAnnapolis, Maryland, United States
Health Sciences America, LLC
๐บ๐ธBoca Raton, Florida, United States
Brian Teliho, MD
๐บ๐ธAtlanta, Georgia, United States
Serenity Center for Depression, P.A.
๐บ๐ธSugar Land, Texas, United States
Orange County TMS Center
๐บ๐ธLaguna Hills, California, United States
Hartford Hospital
๐บ๐ธHartford, Connecticut, United States
Rush University Medical Center
๐บ๐ธChicago, Illinois, United States
Carl M. Wahlstrom, Jr. MD Limited
๐บ๐ธChicago, Illinois, United States
Sheppard Pratt Health System
๐บ๐ธBaltimore, Maryland, United States
Bay Psychiatric Associates
๐บ๐ธBerkeley, California, United States
Clinical Training & Research Institute
๐บ๐ธBurlingame, California, United States
Martha Koo, MD
๐บ๐ธHermosa Beach, California, United States
Comprehensive Psychiatric Care
๐บ๐ธNorwich, Connecticut, United States
Integrative Psychiatry
๐บ๐ธLouisville, Kentucky, United States
Newton-Wellesley Psychiatry
๐บ๐ธNewton, Massachusetts, United States
TMS Center of New England
๐บ๐ธPortsmouth, New Hampshire, United States
W. Scott West, M.D.
๐บ๐ธNashville, Tennessee, United States
Texas TMS Center at Senior Adults Specialty Healthcare (SASH)
๐บ๐ธAustin, Texas, United States
Houston TMS
๐บ๐ธHouston, Texas, United States
Depression Research Center and Clinic-Semel Institute for Neuroscience & Human Behavior at UCLA
๐บ๐ธLos Angeles, California, United States
University Psychiatric Foundation
๐บ๐ธLouisville, Kentucky, United States
Center for Anxiety and Depression
๐บ๐ธMercer Island, Washington, United States
The TMS Institute of Pennsylvania-Advanced Neuropsychiatric Solutions
๐บ๐ธWest Chester, Pennsylvania, United States
Northwestern Medical Faculty Foundation
๐บ๐ธChicago, Illinois, United States
Agape Mind Services/The Costello Clinic
๐บ๐ธLewisville, Texas, United States
University Neuropsychiatric Institute
๐บ๐ธSalt Lake City, Utah, United States
Texas Neuropsychiatric Institute
๐บ๐ธAmarillo, Texas, United States