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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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