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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Brainsway
ClinicalTrials.gov Identifier:
NCT01566591
First received: March 27, 2012
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Bipolar Depression
Device: Deep TMS (H-Coil)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Brainsway:

Primary Outcome Measures:
  • HDRS-21 Score measured by change from baseline. [ Time Frame: 6 weeks from baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical antidepressant remission rate at the 6-week visit [ Time Frame: 6 weeks from baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: May 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Deep TMS (H-Coil)
24 TMS treatments over 6 weeks .
Other Name: H-Coil Deep TMS
Experimental: Active Deep TMS
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
Device: Deep TMS (H-Coil)
24 TMS treatments over 6 weeks .
Other Name: H-Coil Deep TMS

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

  Eligibility

Ages Eligible for Study:   22 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566591

Locations
United States, California
University of California (UCLA)
Los Angeles, California, United States, 90095
United States, Florida
Advanced Mental Health Care Inc. - Juno Beach
Juno Beach, Florida, United States, 33408
Advanced Mental Health Care Inc. - Royal Palm Beach
Royal Palm Beach, Florida, United States, 33411
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Nebraska
Premier Psychiatric Group
Lincoln, Nebraska, United States, 68526
United States, New Hampshire
Greater Nashua Mental Health Center
Nashua, New Hampshire, United States, 03060
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029
Spectrum Neuroscience
New-York, New York, United States, 10021
Columbia University / New York State Psychiatric Institute
New-York, New York, United States, 10032
United States, North Carolina
Duke Medical Center Department of Psychiatry & Behavioral Sciences
Durham, North Carolina, United States, 27710
United States, South Carolina
Medical Uni. Of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
United States, Texas
Senior Adults Specialty Research
Ausitn, Texas, United States, 78757
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-8898
United States, Virginia
TMS NeuroHealth Centers Tysons Corner (McLean Virginia)
McLean, Virginia, United States, 22102
Canada, Ontario
Center for Addiction and Mental Health (CAMH)
Toronto, Ontario, Canada
Germany
Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität
Munich, Germany
Israel
Beer Yaacov Mental Health Center
Beer Yaacov, Israel
Shalvata Mental Health Center
Hod Hasharon, Israel
Hadasah Ein-Karem Medical Center
Jerusalem, Israel
Lev Hasharon
Netanya, Israel
Italy
University of Florence
Florence, Italy
Sponsors and Collaborators
Brainsway
Investigators
Principal Investigator: Yechiel Levkovitz, MD Shalvata Mental Health Center
  More Information

No publications provided

Responsible Party: Brainsway
ClinicalTrials.gov Identifier: NCT01566591     History of Changes
Other Study ID Numbers: BR-BIP-03
Study First Received: March 27, 2012
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration
Israel: Ethics Commission

Keywords provided by Brainsway:
Bipolar Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Affective Disorders, Psychotic

ClinicalTrials.gov processed this record on September 22, 2014