Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Magnetic Seizure Therapy (MST)
|
Device: Tonica MagPro MST
100% power, vertex placement, 3 times per week for 4 weeks
|
| Active Comparator: Electroconvulsive Therapy (ECT)
|
Device: Thymatron
Right unilateral placement, 3x seizure threshold, 3 times per week for 4 weeks
|
Outcome Measures
Primary Outcome Measures
- Clinical improvement (Hamilton Rating Scale for Depression) [After each treatment and at followups up to 3 months after the treatment course]
Secondary Outcome Measures
- Clinical improvement (Montgomery- Åsberg Rating Scale for Depression) [After each treatment and at followups up to 3 months after the treatment course]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Psychiatry and Psychotherapy - University Hospital | Bonn | Germany | 53105 |
Sponsors and Collaborators
- University Hospital, Bonn
Investigators
- Principal Investigator: Thomas E. Schlaepfer, MD, University Hospital, Bonn
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BSG-05-001