Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Thomas E. Schlaepfer, MD, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00770783
First received: October 9, 2008
Last updated: October 28, 2013
Last verified: October 2013

October 9, 2008
October 28, 2013
February 2005
September 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00770783 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression
Efficacy of Magnetic Seizure Therapy (MST) in Refractory Major Depression

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Major Depression
  • 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
  • Experimental: Magnetic Seizure Therapy (MST)
    Intervention: Device: Tonica MagPro MST
  • Active Comparator: Electroconvulsive Therapy (ECT)
    Intervention: Device: Thymatron
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
May 2014
September 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00770783
BSG-05-001
No
Thomas E. Schlaepfer, MD, University Hospital, Bonn
University Hospital, Bonn
Not Provided
Principal Investigator: Thomas E. Schlaepfer, MD University Hospital, Bonn
University Hospital, Bonn
October 2013

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