Back to resultsBerlin Magnetic Seizure Therapy Depression Trial 01
Primary Purpose
Unipolar Depression, Bipolar Depression
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
magnetic seizure therapy
Sponsored by
About this trial
This is an interventional treatment trial for Unipolar Depression
Eligibility 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
Sites / Locations
- Department of Psychiatry, CC15, CBF, Eschenallee 3
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MST
Arm Description
Outcomes
Primary Outcome Measures
Clinical Improvement (HAMD)
Secondary Outcome Measures
Neurocognitive performance
Full Information
NCT ID
NCT00914680
First Posted
June 3, 2009
Last Updated
July 12, 2018
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT00914680
Brief Title
Berlin Magnetic Seizure Therapy Depression Trial 01
Official Title
Investigation of Efficacy and Tolerability of Magnetic Seizure Therapy in the Treatment of Depression
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unipolar Depression, Bipolar Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MST
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
magnetic seizure therapy
Intervention Description
antidepressant treatment with MST
Primary Outcome Measure Information:
Title
Clinical Improvement (HAMD)
Time Frame
before, after treatment
Secondary Outcome Measure Information:
Title
Neurocognitive performance
Time Frame
before/after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Psychiatry, CC15, CBF, Eschenallee 3
City
Berlin
ZIP/Postal Code
14050
Country
Germany
12. IPD Sharing Statement
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Berlin Magnetic Seizure Therapy Depression Trial 01
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