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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Magnetic Seizure Therapy (MST) in Refractory Major Depression

Resource links provided by NLM:


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: May 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Magnetic Seizure Therapy (MST) Device: Tonica MagPro MST
100% power, vertex placement, 3 times per week for 4 weeks
Active Comparator: Electroconvulsive Therapy (ECT) 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770783

Locations
Germany
Department of Psychiatry and Psychotherapy - University Hospital
Bonn, Germany, 53105
Sponsors and Collaborators
University Hospital, Bonn
Investigators
Principal Investigator: Thomas E. Schlaepfer, MD University Hospital, Bonn
  More Information

No publications provided

Responsible Party: Thomas E. Schlaepfer, MD, Professor of Psychiatry and Psychotherapy, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT00770783     History of Changes
Other Study ID Numbers: BSG-05-001
Study First Received: October 9, 2008
Last Updated: October 28, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014