Retrospective TMS Therapy for Adults With MDD

Examine change in the magnitude of antidepressant effects as a function of number of TMS sessions and to determine whether extended treatment courses, beyond 30 and beyond 36 TMS sessions, result in improved efficacy.

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Key information

Conditions

Major Depressive Disorder (MDD) Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The efficacy of TMS in major depressive disorder (MDD) has markedly improved since the pivotal sham-controlled trials. While this enhanced efficacy has been attributed to use of longer treatment courses, the impact of number of treatment sessions on efficacy has not been adequately evaluated. The study device is the Neuronetics, Inc. NeuroStar® TMS Therapy System (K160703, K201158).The study is a retrospective analysis of real-world data from commercial centers. The data will be gathered from the Neuronetics database called TrakStar which collects records of each patient's treatment. The data will be used only as applicable to the objectives of this study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Male or female.
At least 18 years of age.
Treatment with NeuroStar TMS Therapy.
Treatment date of November 01, 2008 or later.
Patient received at least one treatment with NeuroStar TMS Therapy according to standardized NeuroStar TMS Therapy treatment protocols.
Primary diagnosis of Major Depressive Disorder (MDD) with no comorbid diagnosis.
PHQ-9 scores available at baseline (pre-treatment).
Moderate or greater depression prior to the initial treatment course with NeuroStar TMS Therapy, defined as baseline score on the Physician Health Questionnaire-9 (PHQ- 9) ≥ 10.

Treatment and study plan

TMS

Device

Transcranial Magnetic Stimulation

Primary outcomes

Primary Objective

Time frame: 1 to > 36 sessions for acute treatment sessions or > 6 weeks.

The primary objective of this study are to evaluate the changes in the Patient Health Questionnaire-9 (PHQ-9) total score.

and the rating of Clinical Global Impression - Severity (CGI-S) score following application of extended NeuroStar TMS Therapy compared to baseline.
Primary Objective

Time frame: 1 to > 36 sessions for acute treatment sessions or > 6 weeks.

The primary objective of this study are to evaluate the rating of Clinical Global Impression - Severity (CGI-S) score following application of extended NeuroStar TMS Therapy compared to baseline.

Sponsors and collaborators

Lead sponsor

Neuronetics

Other

Collaborators

Brown University
Columbia University
NAMSA
Nashville NeuroCare Therapy
Sheppard Pratt Health System
Southern California TMS Center
TMS of South Tampa

Registry information

Official study title

A Retrospective Registry Study to Evaluate Extended NeuroStar® TMS Therapy for Adults With Major Depressive Disorder (MDD)

Important dates

Study start: 2008
Primary completion: 2022
Study completion: 2022
First posted: Sep 15, 2022
Registry last updated: Sep 15, 2022

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.

Published trials that share one or more normalized conditions with this study.

Completed