Bipolar DepressionNCT01566591
Safety and Efficacy Study of Deep Transcranial Magnetic Stimulation in Bipolar Depression
A study testing Deep TMS Treatment in people with Bipolar Depression, run by Brainsway at 13 sites in 4 countries.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of H1-Coil deep brain rTMS in subjects with bipolar depression, taking mood stabilizers and 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
- Bipolar Depression
- What is being tested?
- Deep TMS Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 13 sitesin 4 countries
- Study dates
- May 2012to Dec 2021
- 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
- patients suffering from an episode of bipolar depression (BP1 or BP2) according to DSM IV, with the additional requirement of duration for the current episode ≥ 4 weeks and CGI ≥ 4.
- Men and Women Ages 22-68 years.
- Negative answers on safety screening questionnaire for transcranial magnetic stimulation.
- Taking mood stabilizing medication (e.g., Lithium, Lamictal, Tegretol, Topamax, etc.) at a therapeutic dose or atypical antipsychotic medication which was prescribed as mood stabilizers by their treating physician, except for Leponex (Clozapine). According to the treating physician the patient is compliant with taking the mood-stabilizing medication.
Who cannot join
- patients suffering from other diagnoses on axis 1 such as schizophrenia , or suffering from psychotic depression in current episode.
- Diagnosed as suffering from Severe Borderline Personality Disorder or hospitalized due to exacerbation related to of borderline personality disorder. Subjects suffering from any other Severe Personality Disorder will also be excluded.
- Present suicidal risk as assessed by the investigator
- Patients with a bipolar cycle of less than 30 days.
- History of epilepsy or seizure (EXCEPT those therapeutically induced by ECT ) or history of such in first degree relatives.
- Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes.
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- History of head injury.
- History of any metal in the head (outside the mouth).
- Metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.
- Hearing loss.
- 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
- History of cerebrovascular accident
- Transient ischemic attack within two years
- Cerebral aneurysm
- Dementia
- Parkinson's disease
- Huntington's chorea
- Multiple sclerosis
- Current History of substance abuse including alcoholism or history of substance abuse including alcoholism within the past 6 months (except nicotine and caffeine).
- Inadequate communication with the patient.
- Under custodial care.
- Participation currently in another clinical study or enrolled in another clinical study within 30 days prior to this study.
- Participants who suffer from an unstable physical disease such as high blood pressure or acute, unstable cardiac disease
- Use of fluoxetine within 6 weeks of the baseline visit
- Use of a Monoamine Oxidase Inhibitor (MAOI) within 2 weeks of the baseline visit
- Current use of antidepressant medications during the course of the trial.
- Current use of Leponex (Clozapine).
- Previous treatment with TMS
- Women who are breast-feeding
- Known or suspected pregnancy
- Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
United States9 sites
Senior Adults Specialty Research
Austin, Texas, 78757
Johns Hopkins University
Baltimore, Maryland, 21205
Medical Uni. Of South Carolina (MUSC)
Charleston, South Carolina, 29425
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8898
Advanced Mental Health Care Inc. - Juno Beach
Juno Beach, Florida, 33408
Premier Psychiatric Group
Lincoln, Nebraska, 68526
Mount Sinai Hospital
New York, New York, 10029
Advanced Mental Health Care Inc. - Palm Beach
Palm Beach, Florida, 33480
Advanced Mental Health Care Inc. - Royal Palm Beach
Royal Palm Beach, Florida, 33411
Germany1 site
Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität
Munich
About this study
Official title: A Prospective, Double Blind, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the H1-Coil Deep Transcranial Magnetic Stimulation (TMS) in Conjunction With Mood Stabilizers in Subjects With Bipolar Depression
The purpose of the study is to evaluate the efficacy and safety of H1-Coil deep brain rTMS in subjects with bipolar depression, taking mood stabilizers and previously unsuccessfully treated with antidepressant medications.
Read the detailed description
This is a multi center, randomized, double blind study to evaluate the efficacy and safety of H1-Coil deep brain rTMS in subjects with bipolar depression, taking mood stabilizers and previously unsuccessfully treated with antidepressant medications. The study is designed for a period of 8 weeks of which up to 3 weeks subjects will be tapered down from their medications and treated for 5 weeks. Two follow up visits will be performed at week 6 and 8 after the last TMS treatment. Mood and mental status will be closely monitored with standard psychological scales and assessments
- Conditions
- Bipolar Depression
- Being tested
- Deep TMS Treatment, Sham Treatment
- Keywords
- Bipolar Depression
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep TMS TreatmentDevice
24 TMS treatments over 6 weeks .
Sham TreatmentDevice
24 TMS treatments over 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sham Treatment | Sham comparator | 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. Receives: Device: Sham Treatment |
| Deep TMS Treatment | Active comparator | Deep TMS treatment 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. Receives: Device: Deep TMS Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDRS-21 Score measured by change from baseline.
Measured: 6 weeks from baseline
Secondary outcomes (1)
Clinical antidepressant remission rate at the 6-week visit
Measured: 6 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainsway
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yechiel Levkovitz, MD, Principal investigator, Shalvata Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566591
- Sponsor's protocol ID
- BR-BIP-03
- Status last verified
- Jan 2020
- First submitted
- 27 Mar 2012
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double Blind, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the H1-Coil Deep Transcranial Magnetic Stimulation (TMS) in Conjunction With Mood Stabilizers in Subjects With Bipolar Depression
- ClinicalTrials.gov ID
- NCT01566591
- Acronym / sponsor ID
- BR-BIP-03
- Conditions
- Bipolar Depression
- Keywords
- Bipolar Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- BrainswayIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 29 Mar 2012 (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 H1-Coil deep brain rTMS in subjects with bipolar depression, taking mood stabilizers and previously unsuccessfully treated with antidepressant medications.
Detailed description
This is a multi center, randomized, double blind study to evaluate the efficacy and safety of H1-Coil deep brain rTMS in subjects with bipolar depression, taking mood stabilizers and previously unsuccessfully treated with antidepressant medications. The study is designed for a period of 8 weeks of which up to 3 weeks subjects will be tapered down from their medications and treated for 5 weeks. Two follow up visits will be performed at week 6 and 8 after the last TMS treatment. Mood and mental status will be closely monitored with standard psychological scales and assessments
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 |
|---|---|---|
| Sham Treatment | Sham comparator | Device: Sham TreatmentIn 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. |
| Deep TMS Treatment | Active comparator | Device: Deep TMS TreatmentDeep TMS treatment 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. |
Who may qualify
- Ages
- 22 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatients
- patients suffering from an episode of bipolar depression (BP1 or BP2) according to DSM IV, with the additional requirement of duration for the current episode ≥ 4 weeks and CGI ≥ 4.
- Men and Women Ages 22-68 years.
- Negative answers on safety screening questionnaire for transcranial magnetic stimulation.
- Taking mood stabilizing medication (e.g., Lithium, Lamictal, Tegretol, Topamax, etc.) at a therapeutic dose or atypical antipsychotic medication which was prescribed as mood stabilizers by their treating physician, except for Leponex (Clozapine). According to the treating physician the patient is compliant with taking the mood-stabilizing medication.
Key exclusion criteria (33 listed)
- patients suffering from other diagnoses on axis 1 such as schizophrenia , or suffering from psychotic depression in current episode.
- Diagnosed as suffering from Severe Borderline Personality Disorder or hospitalized due to exacerbation related to of borderline personality disorder. Subjects suffering from any other Severe Personality Disorder will also be excluded.
- Present suicidal risk as assessed by the investigator
- Patients with a bipolar cycle of less than 30 days.
- History of epilepsy or seizure (EXCEPT those therapeutically induced by ECT ) or history of such in first degree relatives.
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 |
|---|---|---|
| Deep TMS Treatment24 TMS treatments over 6 weeks . | Device | Deep TMS Treatment |
| Sham Treatment24 TMS treatments over 6 weeks | Device | Sham Treatment |
Primary outcome
HDRS-21 Score measured by change from baseline.
Time frame: 6 weeks from baseline
1 secondary outcome
Clinical antidepressant remission rate at the 6-week visit
Time frame: 6 weeks from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
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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, MD principal investigator
Shalvata Mental Health Center
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep TMS Treatment in people with Bipolar Depression, run by Brainsway at 13 sites in 4 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 5 inclusion and 33 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 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Israel, Canada, Germany. 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?
Results are not available in the source record.
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 Score measured by change from baseline. (time frame: 6 weeks from baseline). 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 4 Feb 2021.