NCT01114477

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Typical duration for all trials

Geographic Reach
1 country

44 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 3, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

November 13, 2015

Status Verified

November 1, 2015

Enrollment Period

2.5 years

First QC Date

April 23, 2010

Last Update Submit

November 11, 2015

Conditions

Keywords

Transcranial magnetic stimulationTMSObservational studyMajor Depression

Outcome Measures

Primary Outcomes (1)

  • Total Score on the Patient Health Questionnaire 9-Item (PHQ-9)

    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 Outcomes (5)

  • Total score for the Clinical Global Impressions-Severity (CGI-S)

    Baseline, 6 weeks and 12 Months

  • Total score for the Inventory of Depressive Symptoms-Self Report (IDS-SR)

    Baseline, 6 weeks and 12 Months

  • Total Score for the EuroQol Questionnaire (EQ-5D)

    Baseline, 6 weeks, and 12 Months.

  • Health Resource Utilization Questionnaire (HRU)

    Baseline, 6 weeks, and 12 Months

  • Short Form 36-Item Questionnaire(SF-36) Individual Factor Scores and General Medical and Mental Health Composite Scores

    Baseline, 6 weeks, and 12 Months.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Major Depressive Disorder

You may not qualify if:

  • Contraindications to treatment with TMS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (44)

Lee Ann Kelley, M.D., PC

Phoenix, Arizona, 85032, United States

Location

Bay Psychiatric Associates

Berkeley, California, 94704, United States

Location

TMS Center of Beverly Hills

Beverly Hills, California, 90210, United States

Location

Clinical Training & Research Institute

Burlingame, California, 94010, United States

Location

Sacramento TMS

El Dorado Hills, California, 95762, United States

Location

Martha Koo, MD

Hermosa Beach, California, 90254, United States

Location

Orange County TMS Center

Laguna Hills, California, 92653, United States

Location

Depression Research Center and Clinic-Semel Institute for Neuroscience & Human Behavior at UCLA

Los Angeles, California, 90024, United States

Location

Kevin Kinback, MD

Mission Viejo, California, 92691, United States

Location

Todd Hutton, MD & Associates

Pasadena, California, 91101, United States

Location

The Botkiss Center for TMS Therapy

San Diego, California, 92130, United States

Location

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

Arjun Reyes, MD

Woodland Hills, California, 91364, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Comprehensive Psychiatric Care

Norwich, Connecticut, 06360, United States

Location

Christiana Care Health Services

Wilmington, Delaware, 19801, United States

Location

Health Sciences America, LLC

Boca Raton, Florida, 33432, United States

Location

Curtis Cassidy, MD

Lakeland, Florida, 33803, United States

Location

Brian Teliho, MD

Atlanta, Georgia, 30305, United States

Location

Carl M. Wahlstrom, Jr. MD Limited

Chicago, Illinois, 60601, United States

Location

Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Brain Stimulation Chicago North Shore

Northbrook, Illinois, 60062, United States

Location

Behavioral Health Care Associates

Schaumburg, Illinois, 60194, United States

Location

University Psychiatric Foundation

Louisville, Kentucky, 40202, United States

Location

Integrative Psychiatry

Louisville, Kentucky, 40222, United States

Location

Spectrum Behavioral Health

Annapolis, Maryland, 21401, United States

Location

Sheppard Pratt Health System

Baltimore, Maryland, 21285, United States

Location

Anthony Drobnick, MD

Saint Michaels, Maryland, 21663, United States

Location

Newton-Wellesley Psychiatry

Newton, Massachusetts, 02462, United States

Location

Central Psychiatry

Las Vegas, Nevada, 89146, United States

Location

TMS Center of New England

Portsmouth, New Hampshire, 03801, United States

Location

Santa Fe TMS Therapy Center

Santa Fe, New Mexico, 87501, United States

Location

Dent Neurosciences Research Center, Inc.

Amherst, New York, 14226, United States

Location

The TMS Institute of Pennsylvania-Advanced Neuropsychiatric Solutions

West Chester, Pennsylvania, 19382, United States

Location

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

W. Scott West, M.D.

Nashville, Tennessee, 37215, United States

Location

Texas Neuropsychiatric Institute

Amarillo, Texas, 79106, United States

Location

Texas TMS Center at Senior Adults Specialty Healthcare (SASH)

Austin, Texas, 78757, United States

Location

Houston TMS

Houston, Texas, 77024, United States

Location

Agape Mind Services/The Costello Clinic

Lewisville, Texas, 75077, United States

Location

Serenity Center for Depression, P.A.

Sugar Land, Texas, 77479, United States

Location

University Neuropsychiatric Institute

Salt Lake City, Utah, 84108, United States

Location

Center for Anxiety and Depression

Mercer Island, Washington, 98040, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Mark Demitrack, MD

    Neuronetics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2010

First Posted

May 3, 2010

Study Start

March 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 13, 2015

Record last verified: 2015-11

Locations