NeuroStar TMS Therapy System: Utilization and Outcomes

Major Depressive Disorder Clinical Trial

Official title:

NeuroStar TMS Therapy System: Data Management, Analysis and Reporting Format for Clinical Treatment Utilization and Outcomes (Protocol no. 19-50001-000,Rev D

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114477
• Other study ID #: 19-50001-000
• Status: Completed
• Phase: N/A
• First received: April 23, 2010
• Last updated: November 11, 2015
• Start date: March 2010
• Est. completion date: September 2012

Study information

• Verified date: November 2015
• Source: Neuronetics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Major Depressive Disorder

Exclusion Criteria:

• Contraindications to treatment with TMS

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Locations

Country	Name	City	State
United States	Texas Neuropsychiatric Institute	Amarillo	Texas
United States	Dent Neurosciences Research Center, Inc.	Amherst	New York
United States	Spectrum Behavioral Health	Annapolis	Maryland
United States	Brian Teliho, MD	Atlanta	Georgia
United States	Texas TMS Center at Senior Adults Specialty Healthcare (SASH)	Austin	Texas
United States	Sheppard Pratt Health System	Baltimore	Maryland
United States	Bay Psychiatric Associates	Berkeley	California
United States	TMS Center of Beverly Hills	Beverly Hills	California
United States	Health Sciences America, LLC	Boca Raton	Florida
United States	Clinical Training & Research Institute	Burlingame	California
United States	Carl M. Wahlstrom, Jr. MD Limited	Chicago	Illinois
United States	Northwestern Medical Faculty Foundation	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Sacramento TMS	El Dorado Hills	California
United States	Hartford Hospital	Hartford	Connecticut
United States	Martha Koo, MD	Hermosa Beach	California
United States	Houston TMS	Houston	Texas
United States	Orange County TMS Center	Laguna Hills	California
United States	Curtis Cassidy, MD	Lakeland	Florida
United States	Central Psychiatry	Las Vegas	Nevada
United States	Agape Mind Services/The Costello Clinic	Lewisville	Texas
United States	Depression Research Center and Clinic-Semel Institute for Neuroscience & Human Behavior at UCLA	Los Angeles	California
United States	Integrative Psychiatry	Louisville	Kentucky
United States	University Psychiatric Foundation	Louisville	Kentucky
United States	Center for Anxiety and Depression	Mercer Island	Washington
United States	Kevin Kinback, MD	Mission Viejo	California
United States	W. Scott West, M.D.	Nashville	Tennessee
United States	Newton-Wellesley Psychiatry	Newton	Massachusetts
United States	Brain Stimulation Chicago North Shore	Northbrook	Illinois
United States	Comprehensive Psychiatric Care	Norwich	Connecticut
United States	Todd Hutton, MD & Associates	Pasadena	California
United States	Lee Ann Kelley, M.D., PC	Phoenix	Arizona
United States	TMS Center of New England	Portsmouth	New Hampshire
United States	Butler Hospital	Providence	Rhode Island
United States	University Neuropsychiatric Institute	Salt Lake City	Utah
United States	The Botkiss Center for TMS Therapy	San Diego	California
United States	Santa Fe TMS Therapy Center	Santa Fe	New Mexico
United States	Behavioral Health Care Associates	Schaumburg	Illinois
United States	Anthony Drobnick, MD	St. Michaels	Maryland
United States	Stanford Hospital and Clinics	Stanford	California
United States	Serenity Center for Depression, P.A.	Sugar Land	Texas
United States	The TMS Institute of Pennsylvania-Advanced Neuropsychiatric Solutions	West Chester	Pennsylvania
United States	Christiana Care Health Services	Wilmington	Delaware
United States	Arjun Reyes, MD	Woodland Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Neuronetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Score on the Patient Health Questionnaire 9-Item (PHQ-9)	The primary outcome measure will reported as the change from baseline through 6 weeks for the total score on the PHQ-9.	Baseline and 6 weeks	No
Secondary	Total score for the Clinical Global Impressions-Severity (CGI-S)	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.	Baseline, 6 weeks and 12 Months	No
Secondary	Total score for the Inventory of Depressive Symptoms-Self Report (IDS-SR)	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.	Baseline, 6 weeks and 12 Months	No
Secondary	Total Score for the EuroQol Questionnaire (EQ-5D)	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.	Baseline, 6 weeks, and 12 Months.	No
Secondary	Health Resource Utilization Questionnaire (HRU)	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.	Baseline, 6 weeks, and 12 Months	No
Secondary	Short Form 36-Item Questionnaire(SF-36) Individual Factor Scores and General Medical and Mental Health Composite Scores	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.	Baseline, 6 weeks, and 12 Months.	No