Text Size

NeuroStar TMS Therapy System: Utilization and Outcomes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neuronetics
ClinicalTrials.gov Identifier:
NCT01114477
First received: April 23, 2010
Last updated: February 18, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Major Depressive Disorder

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Neuronetics:

Primary Outcome Measures:
  • Total Score on the Patient Health Questionnaire 9-Item (PHQ-9) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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:
  • Total score for the Clinical Global Impressions-Severity (CGI-S) [ Time Frame: Baseline, 6 weeks and 12 Months ] [ Designated as safety issue: No ]
    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 Inventory of Depressive Symptoms-Self Report (IDS-SR) [ Time Frame: Baseline, 6 weeks and 12 Months ] [ Designated as safety issue: No ]
    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.

  • Total Score for the EuroQol Questionnaire (EQ-5D) [ Time Frame: Baseline, 6 weeks, and 12 Months. ] [ Designated as safety issue: No ]
    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.

  • Health Resource Utilization Questionnaire (HRU) [ Time Frame: Baseline, 6 weeks, and 12 Months ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 307
Study Start Date: March 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114477

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

No publications provided

Responsible Party: Neuronetics
ClinicalTrials.gov Identifier: NCT01114477     History of Changes
Other Study ID Numbers: 19-50001-000
Study First Received: April 23, 2010
Last Updated: February 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Neuronetics:
Transcranial magnetic stimulation
TMS
Observational study
Major Depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 22, 2013