Safety and Efficacy Study of Deep Transcranial Magnetic Stimulation in Bipolar Depression

February 2, 2021 updated by: Brainsway

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Center for Addiction and Mental Health (CAMH)
  • Germany
      • Munich, Germany
        • Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität
  • Israel
      • Beer Yaacov, Israel
        • Beer Yaacov Mental Health Center
      • Netanya, Israel
        • Lev Hasharon
  • United States
    • Florida
      • Juno Beach, Florida, United States, 33408
        • Advanced Mental Health Care Inc. - Juno Beach
      • Palm Beach, Florida, United States, 33480
        • Advanced Mental Health Care Inc. - Palm Beach
      • Royal Palm Beach, Florida, United States, 33411
        • Advanced Mental Health Care Inc. - Royal Palm Beach
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Premier Psychiatric Group
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical Uni. Of South Carolina (MUSC)
    • Texas
      • Austin, Texas, United States, 78757
        • Senior Adults Specialty Research
      • Dallas, Texas, United States, 75390-8898
        • UT Southwestern Medical Center at Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: 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 Treatment
24 TMS treatments over 6 weeks
Active Comparator: Deep TMS Treatment
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.
Device: Deep TMS Treatment
24 TMS treatments over 6 weeks .

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
HDRS-21 Score measured by change from baseline.
Time Frame: 6 weeks from baseline
6 weeks from baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Clinical antidepressant remission rate at the 6-week visit
Time Frame: 6 weeks from baseline
6 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brainsway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BR-BIP-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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