Berlin Magnetic Seizure Therapy Depression Trial 01

Investigation of Efficacy and Tolerability of Magnetic Seizure Therapy in the Treatment of Depression

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 investigators will perform add-on tests to assess clinical and cognitive response to treatment. It is hypothesized that MST will have an antidepressant efficacy with a beneficial neurocognitive adverse effect profile.

Inclusion Criteria:

• 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 Criteria:

• 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