Berlin Magnetic Seizure Therapy Depression Trial 01

Charité University Medicine Berlin

Status and phase

Completed

Phase 3

Conditions

Bipolar Depression

Unipolar Depression

Treatments

Procedure: magnetic seizure therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00914680

BEMAST1

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

25 to 80 years old

Volunteers

No Healthy Volunteers

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