Status:
UNKNOWN
A Prospective, Comparative Study to Explore the Efficacy and Safety of the Five Channels Multiway Deep Transcranial Magnetic Stimulation (TMS) Device in Subjects With Major Depression Disorder (MDD)
Lead Sponsor:
Shalvata Mental Health Center
Collaborating Sponsors:
Brainsway-moach Ltd.
Conditions:
Depression
Eligibility:
All Genders
18-67 years
Phase:
NA
Brief Summary
The Multiway stimulator is a novel TMS stimulator with several new and unique properties. Currently standard TMS devices include a single channel, and can operate only a single coil. The Multiway stim...
Eligibility Criteria
Inclusion
- Outpatient
- Diagnosed by senior psychiatrist as suffering from major depression episode according to DSM IV using the Structured Clinical Interview for DSM-4 (SCID).
- Rating on HDRS-21\>20.
- Age: 18-68 years.
- Treated for the current depressive episode, at least four weeks, with at least one antidepressant in accepted dose, without improvement, according to their medical chart and ATHF ( antidepressant treatment history form) instruction guidelines .
- Gave informed consent for participation in the study.
- Negative answers on safety screening questionnaire for transcranial magnetic stimulation.
Exclusion
- Diagnosis as suffering from other diagnosis on axis 1 ( like: schizophrenia, bipolar disorder, psychotic depression, 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.
- Any current unstable medical or surgical illness.
- History of seizure or heat convulsion.
- 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, cochlear implants or any medical pumps.
- History of hearing loss.
- History of drug abuse or alcoholism in the last 6 month.
- Pregnancy or not using a reliable method of birth control.
- Systematic and metabolic unstable disorders.
- 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 :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01501825
Start Date
August 1 2012
End Date
August 1 2013
Last Update
July 4 2012
Active Locations (2)
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1
Shalvata Mental Health Center
Hod HaSharon, Israel
2
shalvata MHC
Hod HaSharon, Israel