Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression

This study is currently recruiting participants.

Verified April 2013 by University Hospital, Bonn

Sponsor:

Information provided by (Responsible Party):

Thomas E. Schlaepfer, MD, University Hospital, Bonn

ClinicalTrials.gov Identifier:

NCT00770783

First received: October 9, 2008

Last updated: April 15, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 9, 2008

Last Updated Date

April 15, 2013

Start Date ^ICMJE

February 2005

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00770783 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression

Official Title ^ICMJE

Efficacy of Magnetic Seizure Therapy (MST) in Refractory Major Depression

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Major Depression

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Magnetic Seizure Therapy (MST)
Intervention: Device: Tonica MagPro MST
Active Comparator: Electroconvulsive Therapy (ECT)
Intervention: Device: Thymatron

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sarah Kayser, MD

+49 228 287 15025

Sarah.Kayser@ukb.uni-bonn.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00770783

Other Study ID Numbers ^ICMJE

BSG-05-001

Has Data Monitoring Committee

Responsible Party

Thomas E. Schlaepfer, MD, University Hospital, Bonn

Study Sponsor ^ICMJE

University Hospital, Bonn

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Thomas E. Schlaepfer, MD

University Hospital, Bonn

Information Provided By

University Hospital, Bonn

Verification Date

April 2013

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

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