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

Completed · Not applicable

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT01415154

Run by

Neuronetics

People needed

67

Starts

2011-08-01

Expected to finish

2014-07-01

Last updated by the study team

2025-03-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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;
• 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.

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States
• Sheppard Pratt Health System — Baltimore, Maryland, United States
• Premier Psychiatric Group, L.L.C. — Lincoln, Nebraska, 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

Full record on ClinicalTrials.gov

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