Retrospective TMS Therapy for Adults With MDD

NCT ID: NCT05541302

Last Updated: 2022-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6456 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-01

Study Completion Date

2022-08-31

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorder (MDD)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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1-20 TMS sessions

PHQ 9 ratings during this treatment period

TMS

Intervention Type DEVICE

Transcranial Magnetic Stimulation

21 - 29 TMS sessions

PHQ 9 ratings during this treatment period

TMS

Intervention Type DEVICE

Transcranial Magnetic Stimulation

30 TMS Sessions

PHQ 9 ratings during this treatment period

TMS

Intervention Type DEVICE

Transcranial Magnetic Stimulation

31-36 TMS Sessions

PHQ 9 ratings during this treatment period

TMS

Intervention Type DEVICE

Transcranial Magnetic Stimulation

extended treatment 36 and beyond

PHQ 9 ratings during this treatment period

TMS

Intervention Type DEVICE

Transcranial Magnetic Stimulation

Interventions

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TMS

Transcranial Magnetic Stimulation

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southern California TMS Center

UNKNOWN

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role collaborator

TMS of South Tampa

UNKNOWN

Sponsor Role collaborator

Sheppard Pratt Health System

OTHER

Sponsor Role collaborator

Nashville NeuroCare Therapy

UNKNOWN

Sponsor Role collaborator

NAMSA

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

Neuronetics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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44-50018-000

Identifier Type: -

Identifier Source: org_study_id

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