Retrospective TMS Therapy for Adults With MDD

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

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder (MDD)
• Intervention / Treatment: Device: TMS

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 6456

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population comprises patients who were treated with Extended NeuroStar TMS Therapy for MDD on or after November 8, 2008, and whose treatment information was entered in the Neuronetics TrakStar registry at one of the qualifying participating study sites, and for whom the pre-specified required data elements are available in the TrakStar registry and who satisfy each of the study inclusion criteria and none of the exclusion criteria.

Description

Inclusion Criteria:

1. Male or female.
2. At least 18 years of age.
3. Treatment with NeuroStar TMS Therapy.
4. Treatment date of November 01, 2008 or later.
5. Patient received at least one treatment with NeuroStar TMS Therapy according to standardized NeuroStar TMS Therapy treatment protocols.
6. Primary diagnosis of Major Depressive Disorder (MDD) with no comorbid diagnosis.
7. PHQ-9 scores available at baseline (pre-treatment).
8. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1-20 TMS sessions; PHQ 9 ratings during this treatment period	Device: TMS; Transcranial Magnetic Stimulation
21 - 29 TMS sessions; PHQ 9 ratings during this treatment period	Device: TMS; Transcranial Magnetic Stimulation
30 TMS Sessions; PHQ 9 ratings during this treatment period	Device: TMS; Transcranial Magnetic Stimulation
31-36 TMS Sessions; PHQ 9 ratings during this treatment period	Device: TMS; Transcranial Magnetic Stimulation
extended treatment 36 and beyond; PHQ 9 ratings during this treatment period	Device: TMS; Transcranial Magnetic Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Objective	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.	1 to > 36 sessions for acute treatment sessions or > 6 weeks.
Primary Objective	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.	1 to > 36 sessions for acute treatment sessions or > 6 weeks.

Collaborators and Investigators

• Sponsor: Neuronetics
• Collaborators: Columbia University; Brown University; Sheppard Pratt Health System; NAMSA; Southern California TMS Center; TMS of South Tampa; Nashville NeuroCare Therapy

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2008
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 44-50018-000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No