Clinical trial NCT01566591: Safety and Efficacy Study of Deep Transcranial Magnetic Stimulation in Bipolar Depression
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Depression
Keywords: Bipolar Depression
Lead sponsor: Brainsway
Sponsor class: INDUSTRY
First posted: 2012-03-29
Enrollment: 120
Sex: ALL
Minimum age (years): 22
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: HDRS-21 Score measured by change from baseline.
timeFrame: 6 weeks from baseline
Secondary outcomes:
measure: Clinical antidepressant remission rate at the 6-week visit
timeFrame: 6 weeks from baseline
Other outcomes:
Locations:
city: Juno Beach
country: United States
facility: Advanced Mental Health Care Inc. - Juno Beach
state: Florida
city: Palm Beach
country: United States
facility: Advanced Mental Health Care Inc. - Palm Beach
state: Florida
city: Royal Palm Beach
country: United States
facility: Advanced Mental Health Care Inc. - Royal Palm Beach
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Lincoln
country: United States
facility: Premier Psychiatric Group
state: Nebraska
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Charleston
country: United States
facility: Medical Uni. Of South Carolina (MUSC)
state: South Carolina
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Toronto
country: Canada
facility: Center for Addiction and Mental Health (CAMH)
state: Ontario
city: Munich
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität
city: Beer Yaacov
country: Israel
facility: Beer Yaacov Mental Health Center
city: Netanya
country: Israel
facility: Lev Hasharon
Study officials:
affiliation: Shalvata Mental Health Center
name: Yechiel Levkovitz, MD
role: PRINCIPAL_INVESTIGATOR
References: