Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression

University Hospital Bonn (UKB)

Status and phase

Completed

Phase 3

Conditions

Major Depression

Treatments

Device: Tonica MagPro MST

Device: Thymatron

Study type

Interventional

Funder types

Other

Identifiers

NCT00770783

BSG-05-001

Details and patient eligibility

About

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).

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.