Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression

August 3, 2018 updated by: Thomas E. Schlaepfer, MD, University Hospital, Bonn

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53105
        • Department of Psychiatry and Psychotherapy - University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical improvement (Hamilton Rating Scale for Depression)
Time Frame: After each treatment and at followups up to 3 months after the treatment course
After each treatment and at followups up to 3 months after the treatment course

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical improvement (Montgomery- Åsberg Rating Scale for Depression)
Time Frame: After each treatment and at followups up to 3 months after the treatment course
After each treatment and at followups up to 3 months after the treatment course

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Investigators

  • Principal Investigator: Thomas E. Schlaepfer, MD, University Hospital, Bonn

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2005

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

October 9, 2008

First Submitted That Met QC Criteria

October 9, 2008

First Posted (Estimate)

October 10, 2008

Study Record Updates

Last Update Posted (Actual)

August 6, 2018

Last Update Submitted That Met QC Criteria

August 3, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSG-05-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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