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Sponsored by: |
Shalvata Mental Health Center |
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Information provided by: | Shalvata Mental Health Center |
ClinicalTrials.gov Identifier: | NCT00657735 |
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 treated with antidepressant medications
Condition | Intervention |
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Bipolar Depression |
Device: H-Coil deep TMS Device: sham |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective Double Blind Randomized Controlled Trial To Explore The Tolerability, Safety And Efficacy Of The H1-Coil Deep Transcranial Magnetic Stimulation (TMS) In Subjects With Bipolar Depression |
Estimated Enrollment: | 50 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Deep TMS treatment
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Device: H-Coil deep TMS
20 daily deep rTMS treatments
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2: Sham Comparator
inactive stimulation
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Device: sham
inactive treatment
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Ages Eligible for Study: | 18 Years to 68 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:• Outpatients
Exclusion Criteria:• Diagnosis as suffering from other diagnosis on axis 1 (like: schizophrenia, geriatric depression).
Contact: Yechiel Levkovitz, MD | ylevk@clalit.org.il | |
Contact: Oded Meiron, PhD student | odedmei@clalit.org.il |
Responsible Party: | Shalvata Mental Health center, Hod-Hasharon, Israel ( Dr. Yechiel Levkovitz ) |
Study ID Numbers: | BR-BIP-02 |
Study First Received: | April 8, 2008 |
Last Updated: | April 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00657735 |
Health Authority: | Israel: Ministry of Health |
bipolar depression prefrontal |
cortex antidepressant response |
Affective Disorders, Psychotic Depression Mental Disorders Bipolar Disorder |
Mood Disorders Psychotic Disorders Depressive Disorder Behavioral Symptoms |