Major Depressive DisorderNCT01114477
NeuroStar TMS Therapy System: Utilization and Outcomes
An observational study of Major Depressive Disorder, run by Neuronetics at 44 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 307 participants
- Where
- 44 sitesUnited States
- Study dates
- Mar 2010to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Clinical practice locations providing clinical treatment with the NeuroStar TMS Therapy System.
Who may be able to join
- Major Depressive Disorder
Who cannot join
- Contraindications to treatment with TMS
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Texas Neuropsychiatric Institute
Amarillo, Texas, 79106
Dent Neurosciences Research Center, Inc.
Amherst, New York, 14226
Spectrum Behavioral Health
Annapolis, Maryland, 21401
Brian Teliho, MD
Atlanta, Georgia, 30305
Texas TMS Center at Senior Adults Specialty Healthcare (SASH)
Austin, Texas, 78757
Sheppard Pratt Health System
Baltimore, Maryland, 21285
Bay Psychiatric Associates
Berkeley, California, 94704
TMS Center of Beverly Hills
Beverly Hills, California, 90210
Health Sciences America, LLC
Boca Raton, Florida, 33432
Clinical Training & Research Institute
Burlingame, California, 94010
Carl M. Wahlstrom, Jr. MD Limited
Chicago, Illinois, 60601
Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
Sacramento TMS
El Dorado Hills, California, 95762
Hartford Hospital
Hartford, Connecticut, 06102
Martha Koo, MD
Hermosa Beach, California, 90254
Houston TMS
Houston, Texas, 77024
Orange County TMS Center
Laguna Hills, California, 92653
Curtis Cassidy, MD
Lakeland, Florida, 33803
Central Psychiatry
Las Vegas, Nevada, 89146
Agape Mind Services/The Costello Clinic
Lewisville, Texas, 75077
Depression Research Center and Clinic-Semel Institute for Neuroscience & Human Behavior at UCLA
Los Angeles, California, 90024
University Psychiatric Foundation
Louisville, Kentucky, 40202
Integrative Psychiatry
Louisville, Kentucky, 40222
Center for Anxiety and Depression
Mercer Island, Washington, 98040
Kevin Kinback, MD
Mission Viejo, California, 92691
W. Scott West, M.D.
Nashville, Tennessee, 37215
Newton-Wellesley Psychiatry
Newton, Massachusetts, 02462
Brain Stimulation Chicago North Shore
Northbrook, Illinois, 60062
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360
Todd Hutton, MD & Associates
Pasadena, California, 91101
Lee Ann Kelley, M.D., PC
Phoenix, Arizona, 85032
TMS Center of New England
Portsmouth, New Hampshire, 03801
Butler Hospital
Providence, Rhode Island, 02906
Anthony Drobnick, MD
Saint Michaels, Maryland, 21663
University Neuropsychiatric Institute
Salt Lake City, Utah, 84108
The Botkiss Center for TMS Therapy
San Diego, California, 92130
Santa Fe TMS Therapy Center
Santa Fe, New Mexico, 87501
Behavioral Health Care Associates
Schaumburg, Illinois, 60194
Stanford Hospital and Clinics
Stanford, California, 94305
Serenity Center for Depression, P.A.
Sugar Land, Texas, 77479
The TMS Institute of Pennsylvania-Advanced Neuropsychiatric Solutions
West Chester, Pennsylvania, 19382
Christiana Care Health Services
Wilmington, Delaware, 19801
Arjun Reyes, MD
Woodland Hills, California, 91364
About this study
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
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.
- Conditions
- Major Depressive Disorder
- Keywords
- Transcranial magnetic stimulation, TMS, Observational study, Major Depression
- Medical subject headings
- Depressive Disorder, Major
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks
Secondary outcomes (5)
Total score for the Clinical Global Impressions-Severity (CGI-S)
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.
Measured: Baseline, 6 weeks and 12 Months
Total score for the Inventory of Depressive Symptoms-Self Report (IDS-SR)
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.
Measured: Baseline, 6 weeks and 12 Months
Total Score for the EuroQol Questionnaire (EQ-5D)
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.
Measured: Baseline, 6 weeks, and 12 Months.
Health Resource Utilization Questionnaire (HRU)
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.
Measured: Baseline, 6 weeks, and 12 Months
Short Form 36-Item Questionnaire(SF-36) Individual Factor Scores and General Medical and Mental Health Composite Scores
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.
Measured: Baseline, 6 weeks, and 12 Months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuronetics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Demitrack, MD, Study director, Neuronetics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114477
- Sponsor's protocol ID
- 19-50001-000
- Status last verified
- Nov 2015
- First submitted
- 23 Apr 2010
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25271871Janicak 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.
PubMed 23895940
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01114477
- Acronym / sponsor ID
- 19-50001-000
- Conditions
- Major Depressive Disorder
- Keywords
- Transcranial magnetic stimulation, TMS, Observational study, Major Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- NeuroneticsUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 3 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinical practice locations providing clinical treatment with the NeuroStar TMS Therapy System.
Key inclusion criteria (1 listed)
- Major Depressive Disorder
Key exclusion criteria (1 listed)
- Contraindications to treatment with TMS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Total score for the Clinical Global Impressions-Severity (CGI-S)
Time frame: Baseline, 6 weeks and 12 Months
Total score for the Inventory of Depressive Symptoms-Self Report (IDS-SR)
Time frame: Baseline, 6 weeks and 12 Months
Total Score for the EuroQol Questionnaire (EQ-5D)
Time frame: Baseline, 6 weeks, and 12 Months.
Health Resource Utilization Questionnaire (HRU)
Time frame: Baseline, 6 weeks, and 12 Months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
- Derived from this study: PubMed 25271871Dunner 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.
- Derived from this study: PubMed 23895940Janicak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Demitrack, MD study director
Neuronetics, Inc.
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Neuronetics at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Score on the Patient Health Questionnaire 9-Item (PHQ-9) (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01114477, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2015; AzTrials last refreshed its copy on 31 Oct 2026.