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Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression
This study is currently recruiting participants.
Verified by University Hospital, Bonn, October 2008
Sponsored by: University Hospital, Bonn
Information provided by: University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT00770783
  Purpose

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
Major Depression
Device: Thymatron
Device: Tonica MagPro MST
Phase III

Genetics Home Reference related topics: pyridoxine-dependent epilepsy
MedlinePlus related topics: Depression Seizures
U.S. FDA Resources
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

Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • Clinical improvement (Hamilton Rating Scale for Depression) [ Time Frame: After each treatment and at followups up to 3 months after the treatment course ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical improvement (Montgomery- Åsberg Rating Scale for Depression) [ Time Frame: After each treatment and at followups up to 3 months after the treatment course ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is diagnosed with a major depressive episode (MDE) according to DSM-IV Diagnosis Criteria derived from the SCID.
  • Patient has not had an acceptable clinical response due to failure (resistance) with at least two treatments from different treatment categories during the current MDE.
  • Patient has a score ≥ 20 on the 24-item Hamilton Rating Scale of Depression.
  • Patient is able to give his informed consent to participate in this study and he is able to fulfill the requirements of the study.
  • Patient is a male or nonpregnant female adequately protected from conception. Females of childbearing potential must use an acceptable method of birth control.
  • Convulsive therapy clinically indicated

Exclusion Criteria:

  • Patient currently has a secondary diagnosis of, or signs of, delirium, dementia, amnesia, or other cognitive disorders per DSM-IV.
  • Patient has had or has currently a diagnosis of non-affective psychotic disorder per DSM-IV.
  • Patient has had alcohol or substance dependence within the previous 12 months or abuse within the previous six months other than nicotine dependence or abuse.
  • Patient has a history or diagnosis of clinically relevant cardiac disease.
  • Patient has a history or diagnosis of clinically relevant injury or disease of the central nervous system.
  • Patient has magnetic material in the head.
  • Patient has implanted medical devices such as cardiac pacemaker, vagus nerve stimulator, medical pumps etc.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770783

Contacts
Contact: Sarah Kayser, MD +49 228 287 15025 Sarah.Kayser@ukb.uni-bonn.de

Locations
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    
Sponsors and Collaborators
University Hospital, Bonn
Investigators
Principal Investigator: Thomas E. Schlaepfer, MD University Hospital, Bonn
  More Information

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

Study placed in the following topic categories:
Morphine
Depression
Mental Disorders
Seizures
Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 16, 2009