Efficacy of H7-Coil DTMS Compared to H1-Coil DTMS in Subjects With Major Depression Disorder (MDD)

Status unconfirmed · Not applicable

Conditions studied: Major Depressive Disorder (MDD)

In brief

The purpose of the study is to demonstrate that the efficacy and safety of deep brain rTMS, (Transcranial Magnetic Stimulation) H7-Coil treatment as add on treatment, is as good as the FDA cleared, H1-Coil, in subjects with major depressive disorder that have been previously unsuccessfully treated with antidepressant medications.

Key facts

Study ID

NCT03012724

Run by

Brainsway

People needed

106

Starts

2017-03-30

Expected to finish

2020-12-01

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 or 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
• Capable and willing to provide informed consent and able to adhere to the treatment schedule
• Patient is stable on medication for 2 month and is not expected to change medication during all study period

You may not qualify if…

• Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated):
• Depression secondary to a general medical condition, or substance-induced
• History of substance abuse or dependence within the past 6 month (except nicotine and caffeine)
• Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features, Bipolar disorder, Eating disorder, Obsessive compulsive disorder
• Post-traumatic stress disorder (current or within the past year)
• Current generalized anxiety disorder, panic disorder or social anxiety disorder
• Presence of a personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic)
• Individuals with a significant 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 State Exam score of less than or equal to 24
• Parkinson's disease
• Huntington's chorea
• Multiple sclerosis
• Increased risk of seizure for any reason
• Individuals with hearing loss
• ECT treatment within 3 months prior to the screening visit
• History of treatment with Vagus Nerve Stimulation (VNS)
• History of treatment with Deep Brain Stimulation (DBS)
• Use of any investigational drug within 4 weeks of the randomization visit

Where it is running

• Kadima Neuropsychiatry — La Jolla, California, United States (enrolling)
• CalNeuro Research Group — Los Angeles, California, United States (enrolling)
• Advanced Mental Health Care Inc. - Juno Beach — Juno Beach, Florida, United States (enrolling)
• Advanced Mental Health Care Inc. - Palm Beach — Palm Beach, Florida, United States (enrolling)
• Advanced Mental Health Care Inc. - Royal Palm Beach — Royal Palm Beach, Florida, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• Greenbrook TMS NeuroHealth Centers — McLean, Virginia, United States (enrolling)
• Center for Addiction & Mental Health (CAMH) — Toronto, Ontario, Canada (enrolling)
• Dr. Hadar Shalev — Beersheba, Israel (enrolling)

Full record on ClinicalTrials.gov

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