Retrospective TMS Therapy for Adults With MDD

Completed

• Conditions: Major Depressive Disorder (MDD)
• Interventions: Device: TMS

• Registration Number: NCT05541302
• Lead Sponsor: Neuronetics

Brief Summary

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.

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 Timeline

• Study Start: 2008-11-01
• Primary Completion: 2022-08-30
• Study Completion: 2022-08-31
• Status Verified: 2022-09
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-12
• Last Update Submitted: 2022-09-12
• Study First Posted: 2022-09-15
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6456

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
21 - 29 TMS sessions	TMS	PHQ 9 ratings during this treatment period
30 TMS Sessions	TMS	PHQ 9 ratings during this treatment period
1-20 TMS sessions	TMS	PHQ 9 ratings during this treatment period
31-36 TMS Sessions	TMS	PHQ 9 ratings during this treatment period
extended treatment 36 and beyond	TMS	PHQ 9 ratings during this treatment period

Primary Outcome Measures

Name	Time	Method
Primary Objective	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.