NeuroStar TMS Therapy System: Utilization and Outcomes

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT01114477
• Lead Sponsor: Neuronetics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-30
• Study First Posted: 2010-05-03
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-11
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

Inclusion Criteria

• Major Depressive Disorder

Exclusion Criteria

• Contraindications to treatment with TMS

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Score on the Patient Health Questionnaire 9-Item (PHQ-9)	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

Name	Time	Method
Health Resource Utilization Questionnaire (HRU)	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.
Total score for the Clinical Global Impressions-Severity (CGI-S)	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.
Total Score for the EuroQol Questionnaire (EQ-5D)	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.
Short Form 36-Item Questionnaire(SF-36) Individual Factor Scores and General Medical and Mental Health Composite Scores	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.
Total score for the Inventory of Depressive Symptoms-Self Report (IDS-SR)	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.

Trial Locations

Locations (44)

Lee Ann Kelley, M.D., PC; 🇺🇸 Phoenix, Arizona, United States

Bay Psychiatric Associates; 🇺🇸 Berkeley, California, United States

TMS Center of Beverly Hills; 🇺🇸 Beverly Hills, California, United States

Clinical Training & Research Institute; 🇺🇸 Burlingame, California, United States

Sacramento TMS; 🇺🇸 El Dorado Hills, California, United States

Martha Koo, MD; 🇺🇸 Hermosa Beach, California, United States

Orange County TMS Center; 🇺🇸 Laguna Hills, California, United States

Depression Research Center and Clinic-Semel Institute for Neuroscience & Human Behavior at UCLA; 🇺🇸 Los Angeles, California, United States

Kevin Kinback, MD; 🇺🇸 Mission Viejo, California, United States

Todd Hutton, MD & Associates; 🇺🇸 Pasadena, California, United States

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