Berlin Magnetic Seizure Therapy Depression Trial 01

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00914680
First received: June 3, 2009
Last updated: July 20, 2011
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Unipolar Depression
Bipolar Depression
Procedure: magnetic seizure therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation of Efficacy and Tolerability of Magnetic Seizure Therapy in the Treatment of Depression

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Clinical Improvement (HAMD) [ Time Frame: before, after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurocognitive performance [ Time Frame: before/after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: June 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MST Procedure: magnetic seizure therapy
antidepressant treatment with MST

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914680

Contacts
Contact: Lara Rzesnitzek +49 30 8445 8780 lara.rzesnitzek@charite.de
Contact: Bettina Wächter +49 30 8445 8658 bettina.waechter@charite.de

Locations
Germany
Department of Psychiatry, CC15, CBF, Eschenallee 3 Recruiting
Berlin, Germany, 14050
Contact: Lara Rzesnitzek       lara.rzesnitzek@charite.de   
Contact: Bettina Wächter       bettina.waechter@charite.de   
Principal Investigator: Malek Bajbouj         
Sub-Investigator: Lara Rzesnitzek         
Sub-Investigator: Bettina Wächter         
Sponsors and Collaborators
Charite University, Berlin, Germany
  More Information

Additional Information:
No publications provided

Responsible Party: Malek Bajbouj, Charité
ClinicalTrials.gov Identifier: NCT00914680     History of Changes
Other Study ID Numbers: BEMAST1
Study First Received: June 3, 2009
Last Updated: July 20, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014