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Completed

NCT Number: NCT01114477

NeuroStar TMS Therapy System: Utilization and Outcomes

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Major Depressive Disorder

Exclusion criteria

  • Contraindications to treatment with TMS

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  4. Health Resource Utilization Questionnaire (HRU)

    Time frame: 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.

  5. 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.

    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.

Sponsors and collaborators

Lead sponsor

Neuronetics

Other

Registry information

Official study title

NeuroStar TMS Therapy System: Data Management, Analysis and Reporting Format for Clinical Treatment Utilization and Outcomes (Protocol no. 19-50001-000,Rev D

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 3, 2010
Registry last updated
Nov 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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