Retrospective TMS Therapy for Adults With MDD

Major Depressive Disorder (MDD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05541302
• Other study ID #: 44-50018-000
• Status: Completed
• Start date: November 1, 2008
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2022
• Source: Neuronetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6456
• Est. completion date: August 31, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder (MDD)

Intervention

Device:
• TMS
Transcranial Magnetic Stimulation

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Neuronetics	Brown University, Columbia University, NAMSA, Nashville NeuroCare Therapy, Sheppard Pratt Health System, Southern California TMS Center, TMS of South Tampa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.