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

NCT01566591 | Unknown DMC

• 1 other identifier: BR-BIP-03
• Study Type: interventional
• Target: 120
• Locations: 4 countries
• Sites: 13

Brief 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.

Conditions

Bipolar Depression

Keywords

Bipolar Depression

Outcome Measures

Primary Outcomes (1)

• HDRS-21 Score measured by change from baseline.

  6 weeks from baseline

Secondary Outcomes (1)

• Clinical antidepressant remission rate at the 6-week visit

  6 weeks from baseline

Study Arms (2)

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.

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.

Device: Deep TMS Treatment

Interventions

Deep TMS Treatment DEVICE

24 TMS treatments over 6 weeks .

Deep TMS Treatment

Sham Treatment DEVICE

24 TMS treatments over 6 weeks

Sham Treatment

Eligibility Criteria

• Age: 22 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brainsway: lead

Study Sites (13)

Advanced Mental Health Care Inc. - Juno Beach

Juno Beach, Florida, 33408, United States

Location

Advanced Mental Health Care Inc. - Palm Beach

Palm Beach, Florida, 33480, United States

Location

Advanced Mental Health Care Inc. - Royal Palm Beach

Royal Palm Beach, Florida, 33411, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Premier Psychiatric Group

Lincoln, Nebraska, 68526, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Medical Uni. Of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Senior Adults Specialty Research

Austin, Texas, 78757, United States

Location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390-8898, United States

Location

Center for Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada

Location

Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität

Munich, Germany

Location

Beer Yaacov Mental Health Center

Beer Yaacov, Israel

Location

Lev Hasharon

Netanya, Israel

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Yechiel Levkovitz, MD

  Shalvata Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: March 29, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 4, 2021

Record last verified: 2020-01

Locations

CA (1); DE (1); US (9); IL (2)