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

Sponsor

Brainsway (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03012724

Collaborator

(none)

106

Enrollment

Locations

Arms

44.1

Anticipated Duration (Months)

11.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Mar 30, 2017

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

HDRS-21 Score Change From Baseline [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

Response Rate in HDRS-21 [Week 6 post randomization]
Percentage of patients with reduction in HDRS-21 score from baseline in the H7 group compared to the H1 group
Remission Rate [Week 6 post randomization]
Percentage of patients in remission, at week 6 post-randomization assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 68 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kadima Neuropsychiatry	La Jolla	California	United States	92037
2	CalNeuro Research Group	Los Angeles	California	United States	90024
3	Advanced Mental Health Care Inc. - Juno Beach	Juno Beach	Florida	United States	33408
4	Advanced Mental Health Care Inc. - Palm Beach	Palm Beach	Florida	United States	33480
5	Advanced Mental Health Care Inc. - Royal Palm Beach	Royal Palm Beach	Florida	United States	33411
6	Medical University of South Carolina	Charleston	South Carolina	United States	29425
7	Greenbrook TMS NeuroHealth Centers	McLean	Virginia	United States	22102
8	Center for Addiction & Mental Health (CAMH)	Toronto	Ontario	Canada	M6J 1H4
9	Dr. Hadar Shalev	Be'er Sheva'		Israel