Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression

NCT00770783 | Completed Phase 3

• 1 other identifier: BSG-05-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

• Clinical improvement (Hamilton Rating Scale for Depression)

  After each treatment and at followups up to 3 months after the treatment course

Secondary Outcomes (1)

• Clinical improvement (Montgomery- Åsberg Rating Scale for Depression)

  After each treatment and at followups up to 3 months after the treatment course

Study Arms (2)

Magnetic Seizure Therapy (MST)

EXPERIMENTAL

Device: Tonica MagPro MST

Electroconvulsive Therapy (ECT)

ACTIVE COMPARATOR

Device: Thymatron

Interventions

Thymatron DEVICE

Right unilateral placement, 3x seizure threshold, 3 times per week for 4 weeks

Electroconvulsive Therapy (ECT)

Tonica MagPro MST DEVICE

100% power, vertex placement, 3 times per week for 4 weeks

Magnetic Seizure Therapy (MST)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

Department of Psychiatry and Psychotherapy - University Hospital

Bonn, 53105, Germany

Location

Related Publications (1)

• 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.

  PMID: 34131914 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Thomas E. Schlaepfer, MD

  University Hospital, Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Psychotherapy

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 10, 2008
• Study Start: February 1, 2005
• Primary Completion: September 1, 2013
• Study Completion: May 1, 2014
• Last Updated: August 6, 2018

Record last verified: 2018-08

Locations

DE (1)