Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression

Phase 3

Completed

• Conditions: Major Depression
• Interventions: Device: Tonica MagPro MST; Device: Thymatron

• Registration Number: NCT00770783
• Lead Sponsor: University Hospital, Bonn

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 available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2008-10-09
• Study First Submitted QC: 2008-10-09
• Study First Posted: 2008-10-10
• Primary Completion: 2013-09
• Study Completion: 2014-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-03
• Last Update Posted: 2018-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnetic Seizure Therapy (MST)	Tonica MagPro MST	-
Electroconvulsive Therapy (ECT)	Thymatron	-

Primary Outcome Measures

Name	Time	Method
Clinical improvement (Hamilton Rating Scale for Depression)	After each treatment and at followups up to 3 months after the treatment course

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Psychiatry and Psychotherapy - University Hospital; 🇩🇪 Bonn, Germany