Study of a Repetitive Transcranial Magnetic Stimulation (rTMS) Device for the Treatment of Major Depressive Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

This trial will test the safety and efficacy of a rTMS device for the treatment of major depressive disorder (MDD). It is hypothesized that rTMS will have an antidepressant effect. It is a 10-week, randomized, sham-controlled, multicenter trial in outpatients recruited in both academic and private research centers. It is comprised of three major phases: pre-study screening, acute treatment, and post-treatment taper. Eligible patients will be randomized to one of two rTMS treatment groups. One group will receive active rTMS treatment and one will receive an inactive, or sham, treatment. Each treatment takes about 45 minutes and is done on an outpatient basis. All trial related medical care is provided at no cost to the participant.

Key facts

Study ID

NCT00104611

Run by

Neuronetics

People needed

286

Starts

2004-01-01

Expected to finish

2005-11-01

Last updated by the study team

2013-09-20

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 or recurrent episode as confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV), with the additional stipulation of a duration for this episode of greater than or equal to 4 weeks and CGI-S greater than or equal to 4
• Duration of current episode of depression less than 3 years (the definition of an episode is demarcated by a period of greater than or equal to 2 months when the patient did not meet full criteria for the DSM-IV definition of major depressive episode);
• Total HAM-D17 score of greater than or equal to 20 and Item 1 score greater than or equal to 2 at screening visit;
• Medication resistance to at least two different antidepressant treatments, defined as resistance to a minimum of 1 and a maximum of 4 antidepressant drug trials of adequate dose and duration in the current episode with adequate dose and duration defined as minimum level 3 on the Antidepressant Treatment History Form (ATHF); or, if patient has not received a sufficient number of antidepressant treatments to assess their medication resistance in the current episode, then the patient must meet level 3 medication resistance by ATHF criteria to at least 1 and no more than 4 drug trials in a previous episode.
• Patients who have not completed antidepressant trials of adequate dose and duration due to intolerance to therapy may be included if they have demonstrated intolerance to greater than or equal to 4 anti-depressant medications in the current or a previous episode, and did not meet ATHF criteria for a single adequate treatment trial in the current 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)
• 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
• Any history of seizure EXCEPT those therapeutically induced by ECT
• History of cerebrovascular accident
• Transient ischemic attack within two years
• Cerebral aneurysm
• Dementia
• Mini Mental Status Exam score of less than or equal to 24
• Parkinson's disease
• Huntington's chorea
• Multiple sclerosis
• Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes
• A true positive response to any question on the Transcranial Magnetic Stimulation Adult Safety Screen questionnaire

Where it is running

• PsyCare — Poway, California, United States
• Stanford University School of Medicine — Stanford, California, United States
• Northwestern University School of Medicine — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• UVA Center for Psychiatric Clinical Research — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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