Bipolar Depression, Unipolar Depression
Conditions
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 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.
Interventions
PROCEDUREmagnetic seizure therapy
antidepressant treatment with MST
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Improvement (HAMD) | before, after treatment |
Secondary
| Measure | Time frame |
|---|---|
| Neurocognitive performance | before/after treatment |
Countries
Germany
Outcome results
None listed