Major Depressive DisorderNCT00927173
Evaluation of the Brainsway Deep Transcranial Magnetic Stimulation (TMS) H-Coil in the Treatment of Major Depression Disorder
A study testing Brainsway H-Coil Deep TMS System in people with Major Depressive Disorder, run by Brainsway at 22 sites in 5 countries.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of deep brain rTMS, (Transcranial Magnetic Stimulation), a new experimental procedure using the H-Coil, in subjects with Major Depressive Disorder that have been previously unsuccessfully treated with antidepressant medications. Read more about this study
- Who is it for?
- Ages 22 to 68 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Brainsway H-Coil Deep TMS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 233 participants
- Where
- 22 sitesin 5 countries
- Study dates
- Sep 2009to Jun 2012
- 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.
- Patients who have not completed antidepressant trials due to intolerance to therapy of 2 or more anti-depressant medications in the current episode.
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- 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.
- Patients able to tolerate psychotropic medication washout and no psychotropics during the treatment, other than benzodiazepine at equivalent daily dose of up to 3 mg lorazepam.
Who cannot join
- A history of schizophrenia, any psychotic disorder, PTSD, bipolar disorder, OCD, eating disorders (e.g., anorexia nervosa, bulimia) or substance abuse
- A history of panic disorder, social anxiety disorder or personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic) as assessed by the investigator to be primary, causing a higher degree of distress or impairment than MDD.
- A history of any significant medical disease (i.e., cardiovascular, gastrointestinal, etc.)
- A history of seizures, at risk for seizure (e.g., history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes or familial or personal history of epilepsy) or have been diagnosed with a seizure disorder.
- Undergone rTMS treatment, Vagus Nerve Stimulation, or Deep Brain Stimulation.
- Received ECT within the last 3 months or failed to respond to ECT treatment.
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- Individuals with a significant neurological disorder or insult including:
- 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
- Parkinson's disease
- Huntington's chorea
- Multiple sclerosis
- Individuals with hearing loss.
- Any intracranial implant such as 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.
- A cardiac pacemaker, implanted medication pump, intracardiac line, or acute, unstable cardiac disease.
- Use of fluoxetine within 6 weeks of the randomization visit.
- Use of a Monoamine Oxidase Inhibitor (MAOI) within 2 weeks of the randomization visit.
- Present suicidal risk as assessed by the investigator.
- Implanted neurostimulators.
- History of abnormal MRI.
- 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
22 sites in 5 countries.
22 sites in 5 countries
United States14 sites
Senior Adults Specialty Research
Austin, Texas, 78757
Johns Hopkins University
Baltimore, Maryland, 21205
McLean Hospital - TMS Services
Belmont, Massachusetts, 02478
Medical Uni. Of South Carolina (MUSC)
Charleston, South Carolina, 29425
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8898
Duke Medical Center Department of Psychiatry & Behavioral Sciences
Durham, North Carolina, 27710
Advanced Mental Health Care Inc. - Juno Beach
Juno Beach, Florida, 33408
University of California (UCLA)
Los Angeles, California, 90095
Greater Nashua Mental Health Center
Nashua, New Hampshire, 03060
Neuropharmacology Services
New York, New York, 10021
Columbia University / New York State Psychiatric Institute
New York, New York, 10032
Advanced Mental Health Care Inc. - Royal Palm Beach
Royal Palm Beach, Florida, 33411
UC Davis Center for Mind & Brain
Sacramento and Davis, California, 95817
Smart Brain and Health
Santa Monica, California, 90403
Israel4 sites
Beer Yaacov Mental Health Center
Beer Yaacov
Shalvata Mental Health Center
Hod HaSharon
Hadasah Ein-Karem Medical Center
Jerusalem
Kfar Shaul Mental Health Center
Jerusalem
Germany2 sites
Universitätsklinikum Bonn, Klinik und Poliklinik für Psychiatrie und Psychotherapie
Bonn
Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität
Munich
About this study
Official title: A Prospective Multicenter Double Blind Randomized Controlled Trial to Explore the Tolerability, Safety and Efficacy of the H-Coil Deep Transcranial Magnetic Stimulation (TMS) in Subjects With Major Depression Disorder (MDD)
The purpose of the study is to evaluate the efficacy and safety of deep brain rTMS, (Transcranial Magnetic Stimulation), a new experimental procedure using the H-Coil, in subjects with Major Depressive Disorder that have been previously unsuccessfully treated with antidepressant medications.
Read the detailed description
This study is a multicenter, randomized double blind, sham controlled study to evaluate the safety and efficacy of H-coil deep transcranial magnetic stimulation (dTMS) as a treatment for patients with major depressive disorder who have been previously unsuccessfully treated with antidepressant medications. Studies of repetitive transcranial magnetic stimulation (rTMS), typically using a figure-8 coil, have shown that stimulating superficial brain regions can be beneficial in treating major depression. Differing from traditional figure-8 coil, the H-coil is designed to stimulate deep brain regions related to motivation, reward, and pleasure. Preliminary studies have been conducted and seem to indicate that through stimulating certain brain areas with the H-coil, dTMS may have an antidepressant effect. The study population will consist of patients with major depressive disorder who have failed adequate medication treatment or shown significant intolerance to medications. The study duration is 18 weeks, with a 2 week period of weaning the patient off medication, followed by 4 weeks of 5 daily treatments and 12 weeks of biweekly treatments. Mood and mental state will be carefully monitored through standard psychological scales and rating during the drug taper-down and throughout treatment.
- Conditions
- Major Depressive Disorder
- Being tested
- Brainsway H-Coil Deep TMS System, Brainsway H-Coil Deep TMS System (Sham treatment)
- Keywords
- TMS, 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.
Brainsway H-Coil Deep TMS SystemDevice
Deep Transcranial Magnetic Stimulation (DTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The H-coil is a novel DTMS coil designed to allow deeper brain stimulation without a significant increase of electric fields induced in superficial cortical regions
Brainsway H-Coil Deep TMS System (Sham treatment)Device
In the sham treatment,the electrical field induced by the sham coil cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the brain.
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Sham treatment Receives: Device: Brainsway H-Coil Deep TMS System (Sham treatment) |
| Active | Active comparator | Active Deep Transcranial Magnetic Stimulation treatment Receives: Device: Brainsway H-Coil Deep TMS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDRS-21
Measured: 5 weeks
Secondary outcomes (3)
Response rate
Measured: 5 weeks
Remission rates
Measured: 5 weeks
Quality of Life
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brainsway
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yechiel Levkovitz, M.D, Principal investigator, Shalvat Mental Health CenterAbraham Zangen, Dr., Principal investigator, Weizmann Institute of Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927173
- Sponsor's protocol ID
- CTP-0001-00
- Other IDs
- IL-MOH-HTA-4860
- Status last verified
- Feb 2013
- First submitted
- 23 Jun 2009
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
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 Explore the Tolerability, Safety and Efficacy of the H-Coil Deep Transcranial Magnetic Stimulation (TMS) in Subjects With Major Depression Disorder (MDD)
- ClinicalTrials.gov ID
- NCT00927173
- Acronym / sponsor ID
- CTP-0001-00
- Conditions
- Major Depressive Disorder
- Keywords
- TMS, Transcranial Magnetic Stimulation, MDD, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- BrainswayIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 24 Jun 2009 (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 evaluate the efficacy and safety of deep brain rTMS, (Transcranial Magnetic Stimulation), a new experimental procedure using the H-Coil, in subjects with Major Depressive Disorder that have been previously unsuccessfully treated with antidepressant medications.
Detailed description
This study is a multicenter, randomized double blind, sham controlled study to evaluate the safety and efficacy of H-coil deep transcranial magnetic stimulation (dTMS) as a treatment for patients with major depressive disorder who have been previously unsuccessfully treated with antidepressant medications. Studies of repetitive transcranial magnetic stimulation (rTMS), typically using a figure-8 coil, have shown that stimulating superficial brain regions can be beneficial in treating major depression. Differing from traditional figure-8 coil, the H-coil is designed to stimulate deep brain regions related to motivation, reward, and pleasure. Preliminary studies have been conducted and seem to indicate that through stimulating certain brain areas with the H-coil, dTMS may have an antidepressant effect. The study population will consist of patients with major depressive disorder who have failed adequate medication treatment or shown significant intolerance to medications. The study duration is 18 weeks, with a 2 week period of weaning the patient off medication, followed by 4 weeks of 5 daily treatments and 12 weeks of biweekly treatments. Mood and mental state will be carefully monitored through standard psychological scales and rating during the drug taper-down and throughout treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Device: Brainsway H-Coil Deep TMS System (Sham treatment)Sham treatment |
| Active | Active comparator | Device: Brainsway H-Coil Deep TMS SystemActive Deep Transcranial Magnetic Stimulation treatment |
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.
Key exclusion criteria (29 listed)
- A history of schizophrenia, any psychotic disorder, PTSD, bipolar disorder, OCD, eating disorders (e.g., anorexia nervosa, bulimia) or substance abuse
- A history of panic disorder, social anxiety disorder or personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic) as assessed by the investigator to be primary, causing a higher degree of distress or impairment than MDD.
- A history of any significant medical disease (i.e., cardiovascular, gastrointestinal, etc.)
- A history of seizures, at risk for seizure (e.g., history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes or familial or personal history of epilepsy) or have been diagnosed with a seizure disorder.
- Undergone rTMS treatment, Vagus Nerve Stimulation, or Deep Brain Stimulation.
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 |
|---|---|---|
| Brainsway H-Coil Deep TMS SystemDeep Transcranial Magnetic Stimulation (DTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The H-coil is a novel DTMS coil designed to allow deeper brain stimulation without a significant increase of electric fields induced in superficial cortical regions | Device | Active |
| Brainsway H-Coil Deep TMS System (Sham treatment)In the sham treatment,the electrical field induced by the sham coil cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the brain. | Device | Sham |
Primary outcome
HDRS-21
Time frame: 5 weeks
3 secondary outcomes
Response rate
Time frame: 5 weeks
Remission rates
Time frame: 5 weeks
Quality of Life
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
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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.
Yechiel Levkovitz, M.D principal investigator
Shalvat Mental Health Center
Abraham Zangen, Dr. principal investigator
Weizmann Institute of Science
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brainsway H-Coil Deep TMS System in people with Major Depressive Disorder, run by Brainsway at 22 sites in 5 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 29 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: finished, 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 22 sites in United States, Israel, Germany, Canada, France. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HDRS-21 (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.