Status:
UNKNOWN
Double Blind Randomized Controlled, H1 Coil In Subjects With Bipolar Depression
Lead Sponsor:
Shalvata Mental Health Center
Collaborating Sponsors:
Brainsway
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-68 years
Phase:
NA
Brief Summary
The purpose of the study is to explore the efficacy and safety of H1-Coil deep brain rTMS in subjects with bipolar depression , currently treated with mood stabilizer and previously unsuccessfully tre...
Eligibility Criteria
Inclusion
- • Outpatients
- Diagnosed by two senior psychiatrists as suffering from bipolar depression (BP1, BP2) episode according to DSM IV using the Structured Clinical Interview for DSM-4 (SCID), with additional requirement of duration for the current episode ≥ 4 weeks and CGI ≥ 4.
- Rating on HAM-D (17 items) \>20 and item 1 ≥2 at the screening visit.
- Age: 18-65 years.
- Gave informed consent for participation in the study.
- Negative answers on safety screening questionnaire for transcranial magnetic stimulation
- Taking mood stabilizing medication (e.g., lithium) on an acceptable range of dosage according to recent blood examination or antipsychotic medication as mood stabilizers prescribed by their treating physician
- According to the treating physician the patient is compliant in taking the mood-stabilizing medication.
- Medication resistance to at least two different antidepressant treatments, defined as resistance to a minimum of 2 antidepressant drug trials of adequate dose and duration in the current episode or previous episodes defined as a minimum level of 3 on the ATHF per antidepressant drug-trial.
- Patients who have not completed antidepressant trials of adequate dose and duration due to intolerance to therapy may be included if they have demonstrated intolerance to 3 or more anti-depressant medications in the current or a previous episodes.
- If currently taking antidepressant pharmacotherapy, must be clinically appropriate to discontinue treatment with those agents.
- Able to tolerate psychotropic medication washout and no psychotropics during the H-coil deep brain rTMS other than benzodiazepine at equivalent dose of up to 3 mg lorazepam every day.
- Right hand dominance.
Exclusion
- • Diagnosis as suffering from other diagnosis on axis 1 (like: schizophrenia, geriatric depression).
- Diagnosis as suffering from Severe Borderline Personality Disorder or hospitalized due to exacerbation related to of borderline personality disorder.
- Substantial suicidal risk as judged by the treating psychiatrist.
- Attempted suicide in the past year.
- Patients with a bipolar cycle of less than 30 days.
- History of epilepsy or seizure in first degree relatives.
- History of head injury.
- History of any metal in the head (outside the mouth).
- Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
- History of frequent or severe headaches.
- History of migraine.
- History of hearing loss.
- Known history of cochlear implants
- History of substance abuse within the past 6 months (except nicotine and caffeine) or alcoholism
- Pregnancy or not using a reliable method of birth control.
- Unstable Systemic and metabolic disorders.
- Unstable neurological or medical disease
- Inadequate communication with the patient.
- Under custodial care.
- Participation in current clinical study or clinical study within 30 days prior to this study.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00657735
Start Date
January 1 2009
End Date
January 1 2013
Last Update
January 5 2012
Active Locations (1)
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1
shalvataMHC
Hod HaSharon, Israel