Berlin Magnetic Seizure Therapy Depression Trial 01

Bipolar Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00914680
• Other study ID #: BEMAST1
• Status: Completed
• Phase: Phase 3
• Start date: June 2009
• Est. completion date: May 2013

Study information

• Verified date: July 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder
• Seizures
• Unipolar Depression

Intervention

Procedure:
• magnetic seizure therapy
antidepressant treatment with MST

Locations

Country	Name	City	State
Germany	Department of Psychiatry, CC15, CBF, Eschenallee 3	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Improvement (HAMD)		before, after treatment
Secondary	Neurocognitive performance		before/after treatment

External Links

•   Link