NeuroStar TMS Therapy System: Utilization and Outcomes

November 11, 2015 updated by: Neuronetics

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

307

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Lee Ann Kelley, M.D., PC
    • California
      • Berkeley, California, United States, 94704
        • Bay Psychiatric Associates
      • Beverly Hills, California, United States, 90210
        • TMS Center of Beverly Hills
      • Burlingame, California, United States, 94010
        • Clinical Training & Research Institute
      • El Dorado Hills, California, United States, 95762
        • Sacramento TMS
      • Hermosa Beach, California, United States, 90254
        • Martha Koo, MD
      • Laguna Hills, California, United States, 92653
        • Orange County TMS Center
      • Los Angeles, California, United States, 90024
        • Depression Research Center and Clinic-Semel Institute for Neuroscience & Human Behavior at UCLA
      • Mission Viejo, California, United States, 92691
        • Kevin Kinback, MD
      • Pasadena, California, United States, 91101
        • Todd Hutton, MD & Associates
      • San Diego, California, United States, 92130
        • The Botkiss Center for TMS Therapy
      • Stanford, California, United States, 94305
        • Stanford Hospital and Clinics
      • Woodland Hills, California, United States, 91364
        • Arjun Reyes, MD
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • Norwich, Connecticut, United States, 06360
        • Comprehensive Psychiatric Care
    • Delaware
      • Wilmington, Delaware, United States, 19801
        • Christiana Care Health Services
    • Florida
      • Boca Raton, Florida, United States, 33432
        • Health Sciences America, Llc
      • Lakeland, Florida, United States, 33803
        • Curtis Cassidy, MD
    • Georgia
      • Atlanta, Georgia, United States, 30305
        • Brian Teliho, MD
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern Medical Faculty Foundation
      • Chicago, Illinois, United States, 60601
        • Carl M. Wahlstrom, Jr. MD Limited
      • Northbrook, Illinois, United States, 60062
        • Brain Stimulation Chicago North Shore
      • Schaumburg, Illinois, United States, 60194
        • Behavioral Health Care Associates
    • Kentucky
      • Louisville, Kentucky, United States, 40222
        • Integrative Psychiatry
      • Louisville, Kentucky, United States, 40202
        • University Psychiatric Foundation
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Spectrum Behavioral Health
      • Baltimore, Maryland, United States, 21285
        • Sheppard Pratt Health System
      • St. Michaels, Maryland, United States, 21663
        • Anthony Drobnick, MD
    • Massachusetts
      • Newton, Massachusetts, United States, 02462
        • Newton-Wellesley Psychiatry
    • Nevada
      • Las Vegas, Nevada, United States, 89146
        • Central Psychiatry
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • TMS Center of New England
    • New Mexico
      • Santa Fe, New Mexico, United States, 87501
        • Santa Fe TMS Therapy Center
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurosciences Research Center, Inc.
    • Pennsylvania
      • West Chester, Pennsylvania, United States, 19382
        • The TMS Institute of Pennsylvania-Advanced Neuropsychiatric Solutions
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • W. Scott West, M.D.
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Neuropsychiatric Institute
      • Austin, Texas, United States, 78757
        • Texas TMS Center at Senior Adults Specialty Healthcare (SASH)
      • Houston, Texas, United States, 77024
        • Houston TMS
      • Lewisville, Texas, United States, 75077
        • Agape Mind Services/The Costello Clinic
      • Sugar Land, Texas, United States, 77479
        • Serenity Center for Depression, P.A.
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University Neuropsychiatric Institute
    • Washington
      • Mercer Island, Washington, United States, 98040
        • Center For Anxiety and Depression

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Clinical practice locations providing clinical treatment with the NeuroStar TMS Therapy System.

Description

Inclusion Criteria:

  • Major Depressive Disorder

Exclusion Criteria:

  • Contraindications to treatment with TMS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Score on the Patient Health Questionnaire 9-Item (PHQ-9)
Time Frame: 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.
Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total score for the Clinical Global Impressions-Severity (CGI-S)
Time Frame: 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.
Baseline, 6 weeks and 12 Months
Total score for the Inventory of Depressive Symptoms-Self Report (IDS-SR)
Time Frame: 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.
Baseline, 6 weeks and 12 Months
Total Score for the EuroQol Questionnaire (EQ-5D)
Time Frame: 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.
Baseline, 6 weeks, and 12 Months.
Health Resource Utilization Questionnaire (HRU)
Time Frame: 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.
Baseline, 6 weeks, and 12 Months
Short Form 36-Item Questionnaire(SF-36) Individual Factor Scores and General Medical and Mental Health Composite Scores
Time Frame: 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.
Baseline, 6 weeks, and 12 Months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuronetics

Investigators

  • Study Director: Mark Demitrack, MD, Neuronetics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

April 23, 2010

First Submitted That Met QC Criteria

April 30, 2010

First Posted (Estimate)

May 3, 2010

Study Record Updates

Last Update Posted (Estimate)

November 13, 2015

Last Update Submitted That Met QC Criteria

November 11, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-50001-000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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