Status:
COMPLETED
Berlin Magnetic Seizure Therapy Depression Trial 01
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Unipolar Depression
Bipolar Depression
Eligibility:
All Genders
25-80 years
Phase:
PHASE3
Brief Summary
This treatment pilot study will investigate clinical efficacy and adverse effects of magnetic seizure therapy (MST) in patients currently experiencing a unipolar or bipolar depressive episode. The inv...
Eligibility Criteria
Inclusion
- Patient is diagnosed with a severe major depressive episode
- Patient is in a chronic current MDE and/or has had a history of recurrent MDEs
- Patient has not had an acceptable clinical response due to failure with at least 2 antidepressant treatments during the current episode
- Patient has a score \> 20 on the HAMD24
- Patient is stable on current psychotropic medication for at least 4 weeks
- Patient is \> 25 and \< 80 years
Exclusion
- Atypical Depression or psychotic depression (according to DSM IV)
- Other relevant psychiatric axis I or axis II diseases
- Relevant neurological diseases
- Relevant cardiac or pulmonary diseases with enhances anesthesiological risk (ASA Score \> 3)
- Patient is currently enrolled in another investigational study not associated with the current study
- Patient has a history of, or evidence of, significant brain malformation or significant head injury
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00914680
Start Date
June 1 2009
End Date
May 1 2013
Last Update
July 13 2018
Active Locations (1)
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1
Department of Psychiatry, CC15, CBF, Eschenallee 3
Berlin, Germany, 14050