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Berlin Magnetic Seizure Therapy Depression Trial 01

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00914680
First Posted: June 5, 2009
Last Update Posted: July 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Charite University, Berlin, Germany
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Neurocognitive performance [ Time Frame: before/after treatment ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Malek Bajbouj, Charité
ClinicalTrials.gov Identifier: NCT00914680     History of Changes
Other Study ID Numbers: BEMAST1
First Submitted: June 3, 2009
First Posted: June 5, 2009
Last Update Posted: July 22, 2011
Last Verified: June 2009

Additional relevant MeSH terms:
Depression
Depressive Disorder
Seizures
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Bipolar and Related Disorders