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Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression

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ClinicalTrials.gov Identifier: NCT00770783
Recruitment Status : Completed
First Posted : October 10, 2008
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas E. Schlaepfer, MD, University Hospital, Bonn

Tracking Information
First Submitted Date  ICMJE October 9, 2008
First Posted Date  ICMJE October 10, 2008
Last Update Posted Date August 6, 2018
Actual Study Start Date  ICMJE February 2005
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
Clinical improvement (Hamilton Rating Scale for Depression) [ Time Frame: After each treatment and at followups up to 3 months after the treatment course ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00770783 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2008)
Clinical improvement (Montgomery- Åsberg Rating Scale for Depression) [ Time Frame: After each treatment and at followups up to 3 months after the treatment course ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression
Official Title  ICMJE Efficacy of Magnetic Seizure Therapy (MST) in Refractory Major Depression
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depression
Intervention  ICMJE
  • Device: Thymatron
    Right unilateral placement, 3x seizure threshold, 3 times per week for 4 weeks
  • Device: Tonica MagPro MST
    100% power, vertex placement, 3 times per week for 4 weeks
Study Arms  ICMJE
  • Experimental: Magnetic Seizure Therapy (MST)
    Intervention: Device: Tonica MagPro MST
  • Active Comparator: Electroconvulsive Therapy (ECT)
    Intervention: Device: Thymatron
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 9, 2008)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00770783
Other Study ID Numbers  ICMJE BSG-05-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas E. Schlaepfer, MD, University Hospital, Bonn
Study Sponsor  ICMJE University Hospital, Bonn
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas E. Schlaepfer, MD University Hospital, Bonn
PRS Account University Hospital, Bonn
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP