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

July 13, 2020 updated by: Brainsway

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6J 1H4
        • Recruiting
        • Center for Addiction & Mental Health (CAMH)
        • Contact:
  • Israel
      • Be'er Sheva', Israel
  • United States
    • California
      • La Jolla, California, United States, 92037
      • Los Angeles, California, United States, 90024
        • Recruiting
        • CalNeuro Research Group
        • Contact:
        • Principal Investigator:
          • Alexander Bystritsky
    • Florida
      • Juno Beach, Florida, United States, 33408
        • Recruiting
        • Advanced Mental Health Care Inc. - Juno Beach
        • Contact:
      • Palm Beach, Florida, United States, 33480
        • Recruiting
        • Advanced Mental Health Care Inc. - Palm Beach
        • Contact:
          • Elyssa Sisko
          • Phone Number: 561-333-8884
        • Contact:
          • Phone Number: 561-386-1600
        • Principal Investigator:
          • Aron Tendler
      • Royal Palm Beach, Florida, United States, 33411
        • Recruiting
        • Advanced Mental Health Care Inc. - Royal Palm Beach
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
    • Virginia
      • McLean, Virginia, United States, 22102
        • Recruiting
        • Greenbrook TMS NeuroHealth Centers
        • Contact:
        • Contact:
          • Kirsten Burke
          • Phone Number: 703-356-1568
        • Principal Investigator:
          • Geoffrey Grammer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 68 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 6 post randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 6 post randomization
Remission Rate
Time Frame: Week 6 post randomization
Percentage of patients in remission, at week 6 post-randomization assessment
Week 6 post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brainsway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 30, 2017

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

January 5, 2017

First Submitted That Met QC Criteria

January 5, 2017

First Posted (ESTIMATE)

January 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP-0001-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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