Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression
Primary Purpose
Major Depression
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Thymatron
Tonica MagPro MST
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression
Eligibility 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.
Sites / Locations
- Department of Psychiatry and Psychotherapy - University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Magnetic Seizure Therapy (MST)
Electroconvulsive Therapy (ECT)
Arm Description
Outcomes
Primary Outcome Measures
Clinical improvement (Hamilton Rating Scale for Depression)
Secondary Outcome Measures
Clinical improvement (Montgomery- Åsberg Rating Scale for Depression)
Full Information
NCT ID
NCT00770783
First Posted
October 9, 2008
Last Updated
August 3, 2018
Sponsor
University Hospital, Bonn
1. Study Identification
Unique Protocol Identification Number
NCT00770783
Brief Title
Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression
Official Title
Efficacy of Magnetic Seizure Therapy (MST) in Refractory Major Depression
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2005 (Actual)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Bonn
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Magnetic Seizure Therapy (MST)
Arm Type
Experimental
Arm Title
Electroconvulsive Therapy (ECT)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Thymatron
Intervention Description
Right unilateral placement, 3x seizure threshold, 3 times per week for 4 weeks
Intervention Type
Device
Intervention Name(s)
Tonica MagPro MST
Intervention Description
100% power, vertex placement, 3 times per week for 4 weeks
Primary Outcome Measure Information:
Title
Clinical improvement (Hamilton Rating Scale for Depression)
Time Frame
After each treatment and at followups up to 3 months after the treatment course
Secondary Outcome Measure Information:
Title
Clinical improvement (Montgomery- Åsberg Rating Scale for Depression)
Time Frame
After each treatment and at followups up to 3 months after the treatment course
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas E. Schlaepfer, MD
Organizational Affiliation
University Hospital, Bonn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy - University Hospital
City
Bonn
ZIP/Postal Code
53105
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
34131914
Citation
Jiang J, Zhang C, Li C, Chen Z, Cao X, Wang H, Li W, Wang J. Magnetic seizure therapy for treatment-resistant depression. Cochrane Database Syst Rev. 2021 Jun 16;6(6):CD013528. doi: 10.1002/14651858.CD013528.pub2.
Results Reference
derived
Learn more about this trial
Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression
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