Status:
COMPLETED
Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression
Lead Sponsor:
University Hospital, Bonn
Conditions:
Major Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 effic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00770783
Start Date
February 1 2005
End Date
May 1 2014
Last Update
August 6 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Psychiatry and Psychotherapy - University Hospital
Bonn, Germany, 53105