Berlin Magnetic Seizure Therapy Depression Trial 01

July 12, 2018 updated by: Malek Bajbouj, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14050
        • Department of Psychiatry, CC15, CBF, Eschenallee 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MST
Procedure: magnetic seizure therapy
antidepressant treatment with MST

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Improvement (HAMD)
Time Frame: before, after treatment
before, after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Neurocognitive performance
Time Frame: before/after treatment
before/after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

June 3, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (Estimate)

June 5, 2009

Study Record Updates

Last Update Posted (Actual)

July 13, 2018

Last Update Submitted That Met QC Criteria

July 12, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEMAST1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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