Efficacy of H7-Coil DTMS Compared to H1-Coil DTMS in Subjects With Major Depression Disorder (MDD)
NCT ID: NCT03012724
Last Updated: 2020-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
106 participants
INTERVENTIONAL
2017-03-30
2020-12-31
Brief Summary
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Detailed Description
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Approximately 146 subjects will be enrolled in the study. The study population consists of subjects with MDD who have failed adequate medication treatment and who are in a current depressive episode.
The patients will be of all racial, ethnic and gender categories, ranging from 22 to 68 years of age, and have HDRS-21≥20. Outpatients will be recruited from both academic and private research centers.
The study duration is 8 weeks, with a 2 week period of screening and baseline, followed by 4 weeks of 5 daily treatments and 2 weeks of biweekly treatments. Mood and mental state will be carefully monitored through standard psychological scales and assessments during the screening and baseline and throughout treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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H1-Coil
Device: Brainsway H1-Coil Deep TMS System. An FDA cleared deep transcranial magnetic stimulation device. The coil is designed to allow deeper brain stimulation in the lateral prefrontal cortex, including the anterior cingulated cortex without a significant increase of electric fields induced in superficial cortical regions.
H1-Coil
Deep transcranial magnetic stimulation for the treatment of major depression disorder with the FDA cleared H1-Coil
H7-Coil
Device: Brainsway H7-Coil Deep TMS System. A deep transcranial magnetic stimulation device. The coil is designed to allow deeper brain stimulation in the medial prefrontal cortex, including the anterior cingulated cortex without a significant increase of electric fields induced in superficial cortical regions.
H7-Coil
Deep transcranial magnetic stimulation for the treatment of major dispersion disorder with the H7-Coil
Interventions
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H7-Coil
Deep transcranial magnetic stimulation for the treatment of major dispersion disorder with the H7-Coil
H1-Coil
Deep transcranial magnetic stimulation for the treatment of major depression disorder with the FDA cleared H1-Coil
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Use of any prohibited study medication(s)
* Present suicidal risk as assessed by the investigator or significant suicide risk
* Any self-inflicted harm in the past 3 months not in the context of suicidal ideation
* Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease
* Intracranial implant (e.g., 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
* Implanted neurostimulators
* History of abnormal MRI
* Known or suspected pregnancy
* If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the rTMS trial
* Clinically significant laboratory abnormality, in the opinion of the Investigator based on CBC and biochemistry
* Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse
* Women: if pregnant, planning on becoming pregnant, or currently nursing
22 Years
68 Years
ALL
No
Sponsors
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Brainsway
INDUSTRY
Responsible Party
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Locations
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Kadima Neuropsychiatry
La Jolla, California, United States
CalNeuro Research Group
Los Angeles, California, United States
Advanced Mental Health Care Inc. - Juno Beach
Juno Beach, Florida, United States
Advanced Mental Health Care Inc. - Palm Beach
Palm Beach, Florida, United States
Advanced Mental Health Care Inc. - Royal Palm Beach
Royal Palm Beach, Florida, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Greenbrook TMS NeuroHealth Centers
McLean, Virginia, United States
Center for Addiction & Mental Health (CAMH)
Toronto, Ontario, Canada
Dr. Hadar Shalev
Beersheba, , Israel
Countries
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Central Contacts
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Facility Contacts
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Elyssa Sisko
Role: primary
Role: backup
Kirsten Burke
Role: backup
References
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Zangen A, Zibman S, Tendler A, Barnea-Ygael N, Alyagon U, Blumberger DM, Grammer G, Shalev H, Gulevski T, Vapnik T, Bystritsky A, Filipcic I, Feifel D, Stein A, Deutsch F, Roth Y, George MS. Pursuing personalized medicine for depression by targeting the lateral or medial prefrontal cortex with Deep TMS. JCI Insight. 2023 Feb 22;8(4):e165271. doi: 10.1172/jci.insight.165271.
Other Identifiers
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CTP-0001-01
Identifier Type: -
Identifier Source: org_study_id
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