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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

120

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

May 1, 2012

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

March 27, 2012

First Submitted That Met QC Criteria

March 28, 2012

First Posted (Estimate)

March 29, 2012

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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