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Sponsored by: |
University Hospital, Bonn |
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Information provided by: | University Hospital, Bonn |
ClinicalTrials.gov Identifier: | NCT00770783 |
The investigators intend to test in a single center, clinical pilot efficacy study the primary hypothesis that Magnetic Seizure Therapy (MST) as add-on therapy to a controlled pharmacotherapy is efficacious in the treatment of refractory major depression assessed with the Hamilton Depression Rating Scale (HAMD).
Condition | Intervention | Phase |
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Major Depression |
Device: Thymatron Device: Tonica MagPro MST |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of Magnetic Seizure Therapy (MST) in Refractory Major Depression |
Estimated Enrollment: | 30 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Magnetic Seizure Therapy (MST): Experimental |
Device: Tonica MagPro MST
100% power, vertex placement, 3 times per week for 4 weeks
|
Electroconvulsive Therapy (ECT): Active Comparator |
Device: Thymatron
Right unilateral placement, 3x seizure threshold, 3 times per week for 4 weeks
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sarah Kayser, MD | +49 228 287 15025 | Sarah.Kayser@ukb.uni-bonn.de |
Germany | |
Department of Psychiatry and Psychotherapy - University Hospital | Recruiting |
Bonn, Germany, 53105 | |
Contact: Sarah Kayser, MD +49 228 287 15715 sarah.kayser@ukb.uni-bonn.de |
Principal Investigator: | Thomas E. Schlaepfer, MD | University Hospital, Bonn |
Responsible Party: | University Hospital Bonn ( Thomas E. Schlaepfer, MD; Professor of Psychiatry and Psychotherapy ) |
Study ID Numbers: | BSG-05-001 |
Study First Received: | October 9, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00770783 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Morphine Depression Mental Disorders Seizures |
Mood Disorders Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |