Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression
This study is currently recruiting participants.
Verified April 2013 by University Hospital, Bonn
Information provided by (Responsible Party):
Thomas E. Schlaepfer, MD, University Hospital, Bonn
First received: October 9, 2008
Last updated: April 15, 2013
Last verified: April 2013
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).
Device: Tonica MagPro MST
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
||Efficacy of Magnetic Seizure Therapy (MST) in Refractory Major Depression
Primary Outcome Measures:
- Clinical improvement (Hamilton Rating Scale for Depression) [ Time Frame: After each treatment and at followups up to 3 months after the treatment course ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical improvement (Montgomery- Åsberg Rating Scale for Depression) [ Time Frame: After each treatment and at followups up to 3 months after the treatment course ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
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)
Right unilateral placement, 3x seizure threshold, 3 times per week for 4 weeks
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770783
|Department of Psychiatry and Psychotherapy - University Hospital
|Bonn, Germany, 53105 |
|Contact: Sarah Kayser, MD +49 228 287 15715 email@example.com |
University Hospital, Bonn
||Thomas E. Schlaepfer, MD
||University Hospital, Bonn
No publications provided
||Thomas E. Schlaepfer, MD, Professor of Psychiatry and Psychotherapy, University Hospital, Bonn
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 9, 2008
||April 15, 2013
||Germany: Federal Institute for Drugs and Medical Devices
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Depressive Disorder, Major