Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression

Major Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770783
• Other study ID #: BSG-05-001
• Status: Completed
• Phase: Phase 3
• Start date: February 2005
• Est. completion date: May 2014

Study information

• Verified date: August 2018
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression
• Seizures

Intervention

Device:
• Thymatron
Right unilateral placement, 3x seizure threshold, 3 times per week for 4 weeks
• Tonica MagPro MST
100% power, vertex placement, 3 times per week for 4 weeks

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy - University Hospital	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement (Hamilton Rating Scale for Depression)		After each treatment and at followups up to 3 months after the treatment course
Secondary	Clinical improvement (Montgomery- Åsberg Rating Scale for Depression)		After each treatment and at followups up to 3 months after the treatment course