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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Neuronetics
ClinicalTrials.gov Identifier:
NCT01415154
First received: August 10, 2011
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Device: NeuroStar TMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 12-Month Prospective Randomized Dual-Arm Pilot Study of Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Neuronetics:

Primary Outcome Measures:
  • Examining the proportion of patients maintaining a sustained response throughout a 12 month maintenance treatment phase. [ Time Frame: 12 month evaluation ] [ Designated as safety issue: No ]
    Sustained response is defined as not requiring TMS reintroduction at every observation point during the maintenance phase.


Secondary Outcome Measures:
  • Compare the average time to first reintroduction of TMS between the two maintenance treatment arms. [ Time Frame: 12 Month evaluation ] [ Designated as safety issue: No ]
    Change in depressive symptomatology will be assessed across the duration of maintenance treatment using observer and self-administered efficacy measures.


Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Study Completion Date: July 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Scheduled Treatment Arm
3 Week TMS taper, clinical assessments and one NeuroStar TMS session every 4th week of block and TMS reintroduction as needed for clinical deterioration.
Device: NeuroStar TMS
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.
Experimental: Monthly Observational Follow up Arm
3 Week TMS Taper, clinical assessments and office follow up every 4th week of block and NeuroStar TMS reintroduction as needed for clinical deterioration.
Device: NeuroStar TMS
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415154

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
Sheppard Pratt Health System
Baltimore, Maryland, United States, 21285
United States, Nebraska
Premier Psychiatric Group, L.L.C.
Lincoln, Nebraska, United States, 68526
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Washington
Center for Anxiety and Depression
Mercer Island, Washington, United States, 98040
Sponsors and Collaborators
Neuronetics
Investigators
Study Director: David G. Brock, MD Neuronetics
  More Information

No publications provided

Responsible Party: Neuronetics
ClinicalTrials.gov Identifier: NCT01415154     History of Changes
Other Study ID Numbers: 44-03001-000
Study First Received: August 10, 2011
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Neuronetics:
TMS
Major Depressive Disorder
NeuroStar TMS

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 18, 2014