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

Bipolar Depression Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01566591
• Other study ID #: BR-BIP-03
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2012
• Est. completion date: December 2021

Study information

• Verified date: January 2020
• Source: Brainsway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 68 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Device:
• Deep TMS Treatment
24 TMS treatments over 6 weeks .
• Sham Treatment
24 TMS treatments over 6 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Brainsway

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HDRS-21 Score measured by change from baseline.		6 weeks from baseline
Secondary	Clinical antidepressant remission rate at the 6-week visit		6 weeks from baseline