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

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Device: NeuroStar TMS

• Registration Number: NCT01415154
• Lead Sponsor: Neuronetics

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.

Detailed Description

This is a 12-month maintenance treatment study for patients who have responded to a 6 week course of acute TMS treatment for major depressive disorder (MDD). The study will seek to assess the change in depressive symptomatology across the duration of maintenance treatment using observer and self-administered efficacy measures. Describe the efficacy of TMS re-introduction in patients not receiving maintenance pharmacotherapy who show a recurrence of depressive symptoms. Assess the safety and durability of acute TMS therapy followed by maintenance TMS treatment for up to 12 months.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Primary Completion: 2013-09
• Study Completion: 2014-07
• Results First Submitted: 2021-12-23
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Results First Posted: 2025-03-04
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;
  • Transient ischemic attack within two years;
  • Cerebral aneurysm;
  • Dementia;
  • Parkinson's disease;
  • Huntington's chorea;
  • Multiple sclerosis.

• Increased risk of seizure for any reason, including but not limited to prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for ≥ 5 minutes.

• History of treatment with Vagus Nerve Stimulation.

• Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monthly Observational Follow up Arm	NeuroStar TMS	3 Week TMS Taper, clinical assessments and office follow up every 4th week of block and NeuroStar TMS reintroduction as needed for clinical deterioration.
Scheduled Treatment Arm	NeuroStar TMS	3 Week TMS taper, clinical assessments and one NeuroStar TMS session every 4th week of block and TMS reintroduction as needed for clinical deterioration.

Primary Outcome Measures

Name	Time	Method
Number of Patients Maintaining a Sustained Response Throughout a 12 Month Maintenance Treatment Phase.	12 month evaluation	Sustained response is defined as not requiring TMS reintroduction at every observation point during the maintenance phase.

Secondary Outcome Measures

Name	Time	Method
Average Time to First Reintroduction of TMS Between the Two Maintenance Treatment Arms.	12 Month evaluation	Change in depressive symptomatology will be assessed across the duration of maintenance treatment using observer and self-administered efficacy measures.

Trial Locations

Locations (6)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Premier Psychiatric Group, L.L.C.; 🇺🇸 Lincoln, Nebraska, United States

Sheppard Pratt Health System; 🇺🇸 Baltimore, Maryland, United States

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Center for Anxiety and Depression; 🇺🇸 Mercer Island, Washington, United States