Berlin Magnetic Seizure Therapy Depression Trial 01

Phase 3

Completed

• Conditions: Bipolar Depression; Unipolar Depression
• Interventions: Procedure: magnetic seizure therapy

• Registration Number: NCT00914680
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-03
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-05
• Primary Completion: 2012-05
• Study Completion: 2013-05
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-12
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MST	magnetic seizure therapy	-

Primary Outcome Measures

Name	Time	Method
Clinical Improvement (HAMD)	before, after treatment

Secondary Outcome Measures

Name	Time	Method
Neurocognitive performance	before/after treatment

Trial Locations

Locations (1)

Department of Psychiatry, CC15, CBF, Eschenallee 3; 🇩🇪 Berlin, Germany