Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder

NCT01415154 | Completed Results FDA Device

• 1 other identifier: 44-03001-000
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to evaluate the efficacy of scheduled maintenance Transcranial Magnetic Stimulation (TMS) treatment compared to on-demand TMS treatment for symptomatic worsening in patients who have shown a clinical response to acute TMS treatment.

Conditions

Major Depressive Disorder

Keywords

TMS; Major Depressive Disorder; NeuroStar TMS

Outcome Measures

Primary Outcomes (1)

• Number of Patients Maintaining a Sustained Response Throughout a 12 Month Maintenance Treatment Phase.

  Sustained response is defined as not requiring TMS reintroduction at every observation point during the maintenance phase.

  12 month evaluation

Secondary Outcomes (1)

• Average Time to First Reintroduction of TMS Between the Two Maintenance Treatment Arms.

  12 Month evaluation

Study Arms (2)

Scheduled Treatment Arm

ACTIVE COMPARATOR

Following completion of the efficacy assessments at Week 6, One NeuroStar TMS session every four week and TMS reintroduction as needed for clinical deterioration.

Device: NeuroStar TMS

Monthly Observational Follow up Arm

NO INTERVENTION

Following completion of the efficacy assessments at Week 6, Office follow up every 4 week and NeuroStar TMS reintroduction as needed for clinical deterioration.

Interventions

NeuroStar TMS DEVICE

NeuroStar TMS treatmant - 120% of Observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/sessions for 6 days. 3 treatments in taper week 1, 2 treatments in taper week 2 and 1 treatment in taper week 3.

Scheduled Treatment Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary diagnosis by DSM-IV criteria for Major Depressive Episode, single episode or recurrent course of illness, with the additional stipulation of a duration for this episode of ≥ 4 weeks and CGI-S ≥ 4.
• Duration of current episode of depression ≤ 3 years (the definition of an episode is demarcated by a period of ≥ 2 months when the patient did not meet full criteria for the DSM-IV definition of Major Depressive Episode.
• Capable and willing to provide informed consent.
• Signed HIPAA authorization.
• Able to adhere with the treatment schedule, and withdrawal of ongoing pharmacotherapy.
• If currently taking antidepressant pharmacotherapy, must be clinically appropriate to discontinue treatment with those agents.

You may not qualify if:

• Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption).
• Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated):
• Depression secondary to a general medical condition, or substance- induced;
• Seasonal pattern of depression as defined by DSM-IV;
• History of substance abuse or dependence within the past year except nicotine and caffeine);
• Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in this or previous episodes;
• Bipolar disorder;
• Eating disorder (current or within the past year);
• Obsessive compulsive disorder (lifetime); or
• Post-traumatic stress disorder (current or within the past year).
• An Axis II Personality Disorder, which in the judgment of the Investigator may hinder the patient in completing the procedures required by the study protocol.
• Individuals with a clinically defined neurological disorder or insult including, but not limited to:
• Any condition likely to be associated with increased intracranial pressure;
• Space occupying brain lesion;
• History of cerebrovascular accident;

Sponsors & Collaborators

• Neuronetics: lead

Study Sites (6)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Sheppard Pratt Health System

Baltimore, Maryland, 21285, United States

Location

Premier Psychiatric Group, L.L.C.

Lincoln, Nebraska, 68526, United States

Location

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Center for Anxiety and Depression

Mercer Island, Washington, 98040, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Neuronetics

steve.erickson@neurostar.com

16123067393

Study Officials

• David G. Brock, MD

  Neuronetics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: August 11, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: July 1, 2014
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Locations

US (6)