Safety and Efficacy Study of Deep Transcranial Magnetic Stimulation in Bipolar Depression
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Bipolar Depression
In brief
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.
Key facts
- Study ID
- NCT01566591
- Run by
- Brainsway
- People needed
- 120
- Starts
- 2012-05-01
- Expected to finish
- 2021-12-01
- Last updated by the study team
- 2021-02-04
Who can join
Age: 22 and older, up to 68. Sex: any. Healthy volunteers: not accepted.
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
- 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
Where it is running
- Advanced Mental Health Care Inc. - Juno Beach — Juno Beach, Florida, 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, United States
- Johns Hopkins University — Baltimore, Maryland, United States
- Premier Psychiatric Group — Lincoln, Nebraska, United States
- Mount Sinai Hospital — New York, New York, United States
- Medical Uni. Of South Carolina (MUSC) — Charleston, South Carolina, United States
- Senior Adults Specialty Research — Austin, Texas, United States
- UT Southwestern Medical Center at Dallas — Dallas, Texas, United States
- Center for Addiction and Mental Health (CAMH) — Toronto, Ontario, Canada
- Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität — Munich, Germany
- Beer Yaacov Mental Health Center — Beer Yaacov, Israel
- Lev Hasharon — Netanya, Israel
Full record on ClinicalTrials.gov
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