NCT03012724

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
3 countries

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

March 30, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 15, 2020

Status Verified

January 1, 2020

Enrollment Period

3.7 years

First QC Date

January 5, 2017

Last Update Submit

July 13, 2020

Conditions

Major Depressive Disorder (MDD)

Keywords

TMSDeep Transcranial Magnetic StimulationMDDMajor Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • HDRS-21 Score Change From Baseline

    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 Outcomes (2)

  • Response Rate in HDRS-21

    Week 6 post randomization

  • Remission Rate

    Week 6 post randomization

Study Arms (2)

H1-Coil

ACTIVE COMPARATOR

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

H7-Coil

EXPERIMENTAL

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

Interventions

H7-CoilDEVICE

Deep transcranial magnetic stimulation for the treatment of major dispersion disorder with the H7-Coil

H7-Coil
H1-CoilDEVICE

Deep transcranial magnetic stimulation for the treatment of major depression disorder with the FDA cleared H1-Coil

H1-Coil

Eligibility Criteria

Age22 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Kadima Neuropsychiatry

La Jolla, California, 92037, United States

RECRUITING

CalNeuro Research Group

Los Angeles, California, 90024, United States

RECRUITING

Advanced Mental Health Care Inc. - Juno Beach

Juno Beach, Florida, 33408, United States

RECRUITING

Advanced Mental Health Care Inc. - Palm Beach

Palm Beach, Florida, 33480, United States

RECRUITING

Advanced Mental Health Care Inc. - Royal Palm Beach

Royal Palm Beach, Florida, 33411, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Greenbrook TMS NeuroHealth Centers

McLean, Virginia, 22102, United States

RECRUITING

Center for Addiction & Mental Health (CAMH)

Toronto, Ontario, M6J 1H4, Canada

RECRUITING

Dr. Hadar Shalev

Beersheba, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36692954DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Central Study Contacts

Amit Ezra

CONTACT

+972-503103134amite@brainsway.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 6, 2017

Study Start

March 30, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

July 15, 2020

Record last verified: 2020-01

Locations

US(7)IL(1)CA(1)