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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
University Hospital, Bonn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 9, 2008
Last Updated
August 3, 2018
Sponsor
University Hospital, Bonn
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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

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Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression

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