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
Verified date | November 2015 |
Source | Neuronetics |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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.
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 |
Observational Model: Case-Only, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
Neuronetics |
United States,
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 |
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