Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression

NCT ID: NCT00770783

Last Updated: 2018-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2014-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Magnetic Seizure Therapy (MST)

Group Type: EXPERIMENTAL

Tonica MagPro MST

Intervention Type: DEVICE

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

Electroconvulsive Therapy (ECT)

Group Type: ACTIVE_COMPARATOR

Thymatron

Intervention Type: DEVICE

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

Interventions

Thymatron

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

Intervention Type: DEVICE

Tonica MagPro MST

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

Thomas E. Schlaepfer, MD

Professor of Psychiatry and Psychotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas E. Schlaepfer, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bonn

Locations

Department of Psychiatry and Psychotherapy - University Hospital

Bonn, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 34131914 (View on PubMed)

Other Identifiers

BSG-05-001

Identifier Type: -

Identifier Source: org_study_id