Retrospective TMS Therapy for Adults With MDD

Sponsor

Neuronetics (Other)

Overall Status

Completed

CT.gov ID

NCT05541302

Collaborator

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

6,456

Enrollment

165.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder (MDD)	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 Design

Study Type:

Observational

Actual Enrollment :

6456 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Aug 30, 2022

Actual Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Primary Objective [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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-

≥ 10.

Contacts and Locations

Locations

No locations specified.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Neuronetics

ClinicalTrials.gov Identifier:

NCT05541302

Other Study ID Numbers:

44-50018-000

First Posted:

Sep 15, 2022

Last Update Posted:

Sep 15, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Depressive Disorder

Depression

Depressive Disorder, Major

Study Results

No Results Posted as of Sep 15, 2022