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

Charite University, Berlin, Germany1 site in 1 country32 target enrollmentJune 2009

ConditionsUnipolar Depression Bipolar Depression

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Unipolar Depression
Sponsor: Charite University, Berlin, Germany
Enrollment: 32
Locations: 1
Primary Endpoint: Clinical Improvement (HAMD)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

May 2013

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Charite University, Berlin, Germany

Responsible Party

Principal Investigator

Malek Bajbouj

Prof. Dr.

Charite University, Berlin, Germany

Eligibility Criteria

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