Clinical trial NCT01114477: NeuroStar TMS Therapy System: Utilization and Outcomes
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Keywords: Transcranial magnetic stimulation
TMS
Observational study
Major Depression
Lead sponsor: Neuronetics
Sponsor class: OTHER
First posted: 2010-05-03
Enrollment: 307
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical practice locations providing clinical treatment with the NeuroStar TMS Therapy System.

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.


Eligibility criteria: Inclusion Criteria:

* Major Depressive Disorder

Exclusion Criteria:

* Contraindications to treatment with TMS

Primary outcomes:
measure: Total Score on the Patient Health Questionnaire 9-Item (PHQ-9)
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Total score for the Clinical Global Impressions-Severity (CGI-S)
timeFrame: Baseline, 6 weeks and 12 Months
measure: Total score for the Inventory of Depressive Symptoms-Self Report (IDS-SR)
timeFrame: Baseline, 6 weeks and 12 Months
measure: Total Score for the EuroQol Questionnaire (EQ-5D)
timeFrame: Baseline, 6 weeks, and 12 Months.
measure: Health Resource Utilization Questionnaire (HRU)
timeFrame: Baseline, 6 weeks, and 12 Months
measure: Short Form 36-Item Questionnaire(SF-36) Individual Factor Scores and General Medical and Mental Health Composite Scores
timeFrame: Baseline, 6 weeks, and 12 Months.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Lee Ann Kelley, M.D., PC
state: Arizona
city: Berkeley
country: United States
facility: Bay Psychiatric Associates
state: California
city: Beverly Hills
country: United States
facility: TMS Center of Beverly Hills
state: California
city: Burlingame
country: United States
facility: Clinical Training & Research Institute
state: California
city: El Dorado Hills
country: United States
facility: Sacramento TMS
state: California
city: Hermosa Beach
country: United States
facility: Martha Koo, MD
state: California
city: Laguna Hills
country: United States
facility: Orange County TMS Center
state: California
city: Los Angeles
country: United States
facility: Depression Research Center and Clinic-Semel Institute for Neuroscience & Human Behavior at UCLA
state: California
city: Mission Viejo
country: United States
facility: Kevin Kinback, MD
state: California
city: Pasadena
country: United States
facility: Todd Hutton, MD & Associates
state: California
city: San Diego
country: United States
facility: The Botkiss Center for TMS Therapy
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Woodland Hills
country: United States
facility: Arjun Reyes, MD
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Norwich
country: United States
facility: Comprehensive Psychiatric Care
state: Connecticut
city: Wilmington
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Boca Raton
country: United States
facility: Health Sciences America, LLC
state: Florida
city: Lakeland
country: United States
facility: Curtis Cassidy, MD
state: Florida
city: Atlanta
country: United States
facility: Brian Teliho, MD
state: Georgia
city: Chicago
country: United States
facility: Carl M. Wahlstrom, Jr. MD Limited
state: Illinois
city: Chicago
country: United States
facility: Northwestern Medical Faculty Foundation
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Northbrook
country: United States
facility: Brain Stimulation Chicago North Shore
state: Illinois
city: Schaumburg
country: United States
facility: Behavioral Health Care Associates
state: Illinois
city: Louisville
country: United States
facility: University Psychiatric Foundation
state: Kentucky
city: Louisville
country: United States
facility: Integrative Psychiatry
state: Kentucky
city: Annapolis
country: United States
facility: Spectrum Behavioral Health
state: Maryland
city: Baltimore
country: United States
facility: Sheppard Pratt Health System
state: Maryland
city: St. Michaels
country: United States
facility: Anthony Drobnick, MD
state: Maryland
city: Newton
country: United States
facility: Newton-Wellesley Psychiatry
state: Massachusetts
city: Las Vegas
country: United States
facility: Central Psychiatry
state: Nevada
city: Portsmouth
country: United States
facility: TMS Center of New England
state: New Hampshire
city: Santa Fe
country: United States
facility: Santa Fe TMS Therapy Center
state: New Mexico
city: Amherst
country: United States
facility: Dent Neurosciences Research Center, Inc.
state: New York
city: West Chester
country: United States
facility: The TMS Institute of Pennsylvania-Advanced Neuropsychiatric Solutions
state: Pennsylvania
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Nashville
country: United States
facility: W. Scott West, M.D.
state: Tennessee
city: Amarillo
country: United States
facility: Texas Neuropsychiatric Institute
state: Texas
city: Austin
country: United States
facility: Texas TMS Center at Senior Adults Specialty Healthcare (SASH)
state: Texas
city: Houston
country: United States
facility: Houston TMS
state: Texas
city: Lewisville
country: United States
facility: Agape Mind Services/The Costello Clinic
state: Texas
city: Sugar Land
country: United States
facility: Serenity Center for Depression, P.A.
state: Texas
city: Salt Lake City
country: United States
facility: University Neuropsychiatric Institute
state: Utah
city: Mercer Island
country: United States
facility: Center for Anxiety and Depression
state: Washington
Study officials:
affiliation: Neuronetics, Inc.
name: Mark Demitrack, MD
role: STUDY_DIRECTOR
References:
citation: Dunner DL, Aaronson ST, Sackeim HA, Janicak PG, Carpenter LL, Boyadjis T, Brock DG, Bonneh-Barkay D, Cook IA, Lanocha K, Solvason HB, Demitrack MA. A multisite, naturalistic, observational study of transcranial magnetic stimulation for patients with pharmacoresistant major depressive disorder: durability of benefit over a 1-year follow-up period. J Clin Psychiatry. 2014 Dec;75(12):1394-401. doi: 10.4088/JCP.13m08977.
citation: Janicak PG, Dunner DL, Aaronson ST, Carpenter LL, Boyadjis TA, Brock DG, Cook IA, Lanocha K, Solvason HB, Bonneh-Barkay D, Demitrack MA. Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of quality of life outcome measures in clinical practice. CNS Spectr. 2013 Dec;18(6):322-32. doi: 10.1017/S1092852913000357. Epub 2013 Jul 30.