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

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ClinicalTrials.gov Identifier: NCT03012724
Recruitment Status : Recruiting
First Posted : January 6, 2017
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Brainsway

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder (MDD) Device: H7-Coil Device: H1-Coil Not Applicable

Detailed Description:

This is a prospective, 6 week, double blind, randomized, controlled, multi-center trial. The study will explore the safety and efficacy of deep brain rTMS (Transcranial Magnetic Stimulation) H7-Coil treatment and demonstrate that it is as good as the FDA cleared, H1-Coil treatment as add-on for a treatment with antidepressant drugs (a bi-therapeutic treatment ) in subjects with major depressive disorder that have been previously unsuccessfully treated with antidepressant medication.

Approximately 106 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Double Blind Randomized Controlled Trial to Demonstrate That the Efficacy of the H7-Coil is as Good as the Efficacy of the H1-Coil Deep Transcranial Magnetic Stimulation (DTMS) in Subjects With Major Depression Disorder (MDD)
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Device: H1-Coil
Deep transcranial magnetic stimulation for the treatment of major depression disorder with the FDA cleared H1-Coil

Experimental: 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.
Device: H7-Coil
Deep transcranial magnetic stimulation for the treatment of major dispersion disorder with the H7-Coil




Primary Outcome Measures :
  1. HDRS-21 Score Change From Baseline [ Time Frame: Week 6 post randomization ]
    Change from baseline in HDRS-21 scores at week 6 post-randomization in the H7 group compared to the H1 group


Secondary Outcome Measures :
  1. Response Rate in HDRS-21 [ Time Frame: Week 6 post randomization ]
    Percentage of patients with reduction in HDRS-21 score from baseline in the H7 group compared to the H1 group

  2. Remission Rate [ Time Frame: Week 6 post randomization ]
    Percentage of patients in remission, at week 6 post-randomization assessment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012724


Contacts
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Contact: Amit Ezra +972-503103134 amite@brainsway.com

Locations
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United States, California
Kadima Neuropsychiatry Recruiting
La Jolla, California, United States, 92037
Contact: Cheryl Jacobson    858-412-4130    clinicaltrials@kadimanp.com   
Principal Investigator: David Feifel, MD         
CalNeuro Research Group Recruiting
Los Angeles, California, United States, 90024
Contact: Christina Fosteson    310-208-7144    cfosteson@calneuroresearch.com   
Principal Investigator: Alexander Bystritsky         
United States, Florida
Advanced Mental Health Care Inc. - Juno Beach Recruiting
Juno Beach, Florida, United States, 33408
Contact: Elyssa Sisko    561-267-8876    elyssasisko@gmail.com   
Principal Investigator: Aron Tendler, MD         
Advanced Mental Health Care Inc. - Palm Beach Recruiting
Palm Beach, Florida, United States, 33480
Contact: Elyssa Sisko    561-333-8884      
Contact    561-386-1600      
Principal Investigator: Aron Tendler         
Advanced Mental Health Care Inc. - Royal Palm Beach Recruiting
Royal Palm Beach, Florida, United States, 33411
Contact: Elyssa Sisko    561-267-8876    elyssasisko@gmail.com   
Principal Investigator: Aron Tendler, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Morgan Dancy, BsC       maddoxm@musc.edu   
Principal Investigator: Mark George, MD         
United States, Virginia
Greenbrook TMS NeuroHealth Centers Recruiting
McLean, Virginia, United States, 22102
Contact: Jessica Oleksik    703-356-1568    joleksik@greenbrooktms.com   
Contact: Kirsten Burke    703-356-1568      
Principal Investigator: Geoffrey Grammer, MD         
Canada, Ontario
Center for Addiction & Mental Health (CAMH) Recruiting
Toronto, Ontario, Canada, M6J 1H4
Contact: Shobha Mehta    416-5358501 ext 33662    Shobha.Mehta@camh.ca   
Principal Investigator: Daniel Blumberger, MD         
Israel
Dr. Hadar Shalev Recruiting
Be'er Sheva`, Israel
Contact: Tali Gulevsky    +972-8-6479180    gulevsky@post.bgu.ac.il   
Sponsors and Collaborators
Brainsway

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Responsible Party: Brainsway
ClinicalTrials.gov Identifier: NCT03012724     History of Changes
Other Study ID Numbers: CTP-0001-01
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Brainsway:
TMS
Deep Transcranial Magnetic Stimulation
MDD
Major Depressive Disorder
Additional relevant MeSH terms:
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Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders