Evaluation of the Brainsway Deep Transcranial Magnetic Stimulation (TMS) H-Coil in the Treatment of Major Depression Disorder

Completed · Not applicable · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

The purpose of the study is to evaluate the efficacy and safety of deep brain rTMS, (Transcranial Magnetic Stimulation), a new experimental procedure using the H-Coil, in subjects with Major Depressive Disorder that have been previously unsuccessfully treated with antidepressant medications.

Key facts

Study ID

NCT00927173

Run by

Brainsway

People needed

233

Starts

2009-09-01

Expected to finish

2012-06-01

Last updated by the study team

2020-07-15

Who can join

Age: 22 and older, up to 68. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Outpatients.
• Men and women 22-68 years of age.
• Primary DSM-IV diagnosis of Major Depression, single or recurrent episode.
• Current depressive episode is less than 5 years duration.
• The patient did not respond to at least one but not more than four antidepressant treatments in the current episode.
• Patients who have not completed antidepressant trials due to intolerance to therapy of 2 or more anti-depressant medications in the current episode.
• Satisfactory safety screening questionnaire for transcranial magnetic stimulation.
• Patients not suffering from hypo or hyper-thyroidism based on pre-study TSH level or medically stabilized.
• Patients able to tolerate psychotropic medication washout and no psychotropics during the treatment, other than benzodiazepine at equivalent daily dose of up to 3 mg lorazepam.

You may not qualify if…

• A history of schizophrenia, any psychotic disorder, PTSD, bipolar disorder, OCD, eating disorders (e.g., anorexia nervosa, bulimia) or substance abuse
• A history of panic disorder, social anxiety disorder or personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic) as assessed by the investigator to be primary, causing a higher degree of distress or impairment than MDD.
• A history of any significant medical disease (i.e., cardiovascular, gastrointestinal, etc.)
• A history of seizures, at risk for seizure (e.g., history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes or familial or personal history of epilepsy) or have been diagnosed with a seizure disorder.
• Undergone rTMS treatment, Vagus Nerve Stimulation, or Deep Brain Stimulation.
• Received ECT within the last 3 months or failed to respond to ECT treatment.
• Individuals with a significant neurological disorder or insult including:
• 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
• Parkinson's disease
• Huntington's chorea
• Multiple sclerosis
• Individuals with hearing loss.
• Any intracranial implant such as aneurysm clips, shunts, stimulators, cochlear implants, or electrodes, or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
• A cardiac pacemaker, implanted medication pump, intracardiac line, or acute, unstable cardiac disease.
• Use of fluoxetine within 6 weeks of the randomization visit.
• Use of a Monoamine Oxidase Inhibitor (MAOI) within 2 weeks of the randomization visit.
• Present suicidal risk as assessed by the investigator.
• Implanted neurostimulators.
• History of abnormal MRI.

Where it is running

• University of California (UCLA) — Los Angeles, California, United States
• UC Davis Center for Mind & Brain — Sacramento and Davis, California, United States
• Smart Brain and Health — Santa Monica, California, United States
• Advanced Mental Health Care Inc. - Juno Beach — Juno Beach, Florida, United States
• Advanced Mental Health Care Inc. - Royal Palm Beach — Royal Palm Beach, Florida, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• McLean Hospital - TMS Services — Belmont, Massachusetts, United States
• Greater Nashua Mental Health Center — Nashua, New Hampshire, United States
• Neuropharmacology Services — New York, New York, United States
• Columbia University / New York State Psychiatric Institute — New York, New York, United States
• Duke Medical Center Department of Psychiatry & Behavioral Sciences — Durham, North Carolina, United States
• Medical Uni. Of South Carolina (MUSC) — Charleston, South Carolina, United States
• Senior Adults Specialty Research — Austin, Texas, United States
• UT Southwestern Medical Center at Dallas — Dallas, Texas, United States
• Center for Addiction and Mental Health (CAMH) — Toronto, Ontario, Canada
• EPS Ville-Evrard — Neuilly-sur-Marne, France
• Universitätsklinikum Bonn, Klinik und Poliklinik für Psychiatrie und Psychotherapie — Bonn, Germany
• Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität — Munich, Germany
• Beer Yaacov Mental Health Center — Beer Yaacov, Israel
• Shalvata Mental Health Center — Hod HaSharon, Israel
• Hadasah Ein-Karem Medical Center — Jerusalem, Israel
• Kfar Shaul Mental Health Center — Jerusalem, Israel

Full record on ClinicalTrials.gov

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