Retrospective TMS Therapy for Adults With MDD

NCT05541302 | Completed FDA Device

• 1 other identifier: 44-50018-000
• Study Type: observational
• Target: 6,456
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (5)

1-20 TMS sessions

PHQ 9 ratings during this treatment period

Device: TMS

21 - 29 TMS sessions

PHQ 9 ratings during this treatment period

Device: TMS

30 TMS Sessions

PHQ 9 ratings during this treatment period

Device: TMS

31-36 TMS Sessions

PHQ 9 ratings during this treatment period

Device: TMS

extended treatment 36 and beyond

PHQ 9 ratings during this treatment period

Device: TMS

Interventions

TMS DEVICE

Transcranial Magnetic Stimulation

1-20 TMS sessions; 21 - 29 TMS sessions; 30 TMS Sessions; 31-36 TMS Sessions; extended treatment 36 and beyond

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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- 9) ≥ 10.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 15, 2022
• Study Start: November 1, 2008
• Primary Completion: August 30, 2022
• Study Completion: August 31, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share