Major Depressive Disorder (MDD)NCT03012724
Efficacy of H7-Coil DTMS Compared to H1-Coil DTMS in Subjects With Major Depression Disorder (MDD)
A study testing H7-Coil and H1-Coil in people with Major Depressive Disorder (MDD), run by Brainsway at 9 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 68 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- H7-Coil and H1-Coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 30 Mar 2017to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States7 sites, 7 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Morgan Dancy, BsC, maddoxm@musc.edu
Mark George, MD
- Recruiting
Advanced Mental Health Care Inc. - Juno Beach
Juno Beach, Florida, 33408
Elyssa Sisko, 561-267-8876, elyssasisko@gmail.com
Aron Tendler, MD
- Recruiting
Kadima Neuropsychiatry
La Jolla, California, 92037
Cheryl Jacobson, 858-412-4130, clinicaltrials@kadimanp.com
David Feifel, MD
- Recruiting
CalNeuro Research Group
Los Angeles, California, 90024
Christina Fosteson, 310-208-7144, cfosteson@calneuroresearch.com
Alexander Bystritsky
- Recruiting
Greenbrook TMS NeuroHealth Centers
McLean, Virginia, 22102
Jessica Oleksik, 703-356-1568, joleksik@greenbrooktms.com
Kirsten Burke, 703-356-1568
- Recruiting
Advanced Mental Health Care Inc. - Palm Beach
Palm Beach, Florida, 33480
Elyssa Sisko, 561-333-8884
561-386-1600
- Recruiting
Advanced Mental Health Care Inc. - Royal Palm Beach
Royal Palm Beach, Florida, 33411
Elyssa Sisko, 561-267-8876, elyssasisko@gmail.com
Aron Tendler, MD
Canada1 site, 1 recruiting
- Recruiting
Center for Addiction & Mental Health (CAMH)
Toronto, Ontario, M6J 1H4
Shobha Mehta, 416-5358501 ext. 33662, Shobha.Mehta@camh.ca
Daniel Blumberger, MD
Israel1 site, 1 recruiting
- Recruiting
Dr. Hadar Shalev
Beersheba
Tali Gulevsky, +972-8-6479180, gulevsky@post.bgu.ac.il
About this study
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)
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.
Read the 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.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- H7-Coil, H1-Coil
- Keywords
- TMS, Deep Transcranial Magnetic Stimulation, MDD, Major Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H7-CoilDevice
Deep transcranial magnetic stimulation for the treatment of major dispersion disorder with the H7-Coil
H1-CoilDevice
Deep transcranial magnetic stimulation for the treatment of major depression disorder with the FDA cleared H1-Coil
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: H7-Coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 6 post randomization
Secondary outcomes (2)
Response Rate in HDRS-21
Percentage of patients with reduction in HDRS-21 score from baseline in the H7 group compared to the H1 group
Measured: Week 6 post randomization
Remission Rate
Percentage of patients in remission, at week 6 post-randomization assessment
Measured: Week 6 post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start30 Mar 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainsway
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012724
- Sponsor's protocol ID
- CTP-0001-01
- Status last verified
- Jan 2020
- First submitted
- 5 Jan 2017
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 36692954
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03012724
- Acronym / sponsor ID
- CTP-0001-01
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- TMS, Deep Transcranial Magnetic Stimulation, MDD, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- BrainswayIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H1-Coil | Active comparator | Device: H1-CoilDevice: 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. |
| H7-Coil | Experimental | Device: H7-CoilDevice: 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. |
Who may qualify
- Ages
- 22 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (37 listed)
- Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated):
- Individuals with a significant neurological disorder or insult including, but not limited to:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H7-CoilDeep transcranial magnetic stimulation for the treatment of major dispersion disorder with the H7-Coil | Device | H7-Coil |
| H1-CoilDeep transcranial magnetic stimulation for the treatment of major depression disorder with the FDA cleared H1-Coil | Device | H1-Coil |
Primary outcome
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
2 secondary outcomes
Response Rate in HDRS-21
Time frame: Week 6 post randomization
Remission Rate
Time frame: Week 6 post randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Derived from this study: PubMed 36692954Zangen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H7-Coil and H1-Coil in people with Major Depressive Disorder (MDD), run by Brainsway at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amit Ezra (+972-503103134, amite@brainsway.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HDRS-21 Score Change From Baseline (time frame: Week 6 post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03012724, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.