We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

NeuroStar TMS Therapy System: Utilization and Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01114477
Recruitment Status : Completed
First Posted : May 3, 2010
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Major Depressive Disorder

Study Design

Study Type : Observational
Actual Enrollment : 307 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : March 2010
Primary Completion Date : September 2012
Study Completion Date : September 2012
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Clinical practice locations providing clinical treatment with the NeuroStar TMS Therapy System.
Criteria

Inclusion Criteria:

  • Major Depressive Disorder

Exclusion Criteria:

  • Contraindications to treatment with TMS
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01114477


  Show 44 Study Locations
Sponsors and Collaborators
Neuronetics
Investigators
Study Director: Mark Demitrack, MD Neuronetics, Inc.
More Information