Changes in Cerebral Glucose Metabolism After Electroconvulsive Therapy (ECT)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Electroconvulsive therapy
18-Fluoro-desoxy-glucose positron emission tomography
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, FDG-PET, Electroconvulsive therapy, glucose metabolism
Eligibility Criteria
Inclusion Criteria:
- clinical indication for ECT
- treatment refractory depressive episode
- age 18-85 y
Exclusion Criteria:
- addiction as a first diagnosis
- dementia
Sites / Locations
- Medical University Graz; Department for Psychiatry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ECT verum group
Arm Description
Patients with treatment refractory depression treated with ECT
Outcomes
Primary Outcome Measures
Brain glucose metabolism measured by FDG-PET
Secondary Outcome Measures
Full Information
NCT ID
NCT01514435
First Posted
January 11, 2012
Last Updated
January 17, 2012
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT01514435
Brief Title
Changes in Cerebral Glucose Metabolism After Electroconvulsive Therapy (ECT)
Official Title
Clinical Effects of Electroconvulsive Therapy in Severe Depression and Concomitant Changes in Cerebral Glucose Metabolism - an Exploratory Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
There exist already a few studies that have measured changes of brain metabolism pre and post Electroconvulsive Therapy (ECT) by Positron emission tomography (PET) but these were all performed in a small number of patients and used different methodologies. It is therefore not surprising that these investigations provided inconsistent results, as reviewed previously {{23 Schmidt,E.Z. 2008}}.
In patients with treatment-refractory major depressive episodes, the investigators here therefore probed (a) whether changes in cerebral glucose metabolism measured by PET occur after treatment with ECT and (b) whether these correlate with the clinical amelioration of symptoms. To pursue this goal, the investigators assessed clinical effects, neurocognitive function, and brain metabolism using 18F-Fluoro-deoxyglucose (18F-FDG) PET at baseline and at the end of treatment.
Patients with a treatment refractory depression - defined as absent clinical improvement of depressive symptoms after at least two trials with antidepressants from different pharmacologic classes adequate in dose, duration of at least 6 weeks, and compliance {{30 Berlim,M.T. 2007}} - in whom ECT had been intended on clinical grounds were consecutively asked for participation in this study. Patients had to be between 18 and 80 years old and to be physically healthy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, FDG-PET, Electroconvulsive therapy, glucose metabolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ECT verum group
Arm Type
Experimental
Arm Description
Patients with treatment refractory depression treated with ECT
Intervention Type
Device
Intervention Name(s)
Electroconvulsive therapy
Other Intervention Name(s)
no other names
Intervention Description
treatment for major depression
Intervention Type
Device
Intervention Name(s)
18-Fluoro-desoxy-glucose positron emission tomography
Other Intervention Name(s)
no other names
Intervention Description
intravenous injection of 18-FDG, after 30 min PET-Scan of the brain for aprox. 40 min.
It´s a neuroimaging technique.
Primary Outcome Measure Information:
Title
Brain glucose metabolism measured by FDG-PET
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical indication for ECT
treatment refractory depressive episode
age 18-85 y
Exclusion Criteria:
addiction as a first diagnosis
dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernd Reininghaus
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Graz; Department for Psychiatry
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
17444078
Citation
Berlim MT, Turecki G. Definition, assessment, and staging of treatment-resistant refractory major depression: a review of current concepts and methods. Can J Psychiatry. 2007 Jan;52(1):46-54. doi: 10.1177/070674370705200108.
Results Reference
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PubMed Identifier
17662472
Citation
Schmidt EZ, Reininghaus B, Enzinger C, Ebner C, Hofmann P, Kapfhammer HP. Changes in brain metabolism after ECT-positron emission tomography in the assessment of changes in glucose metabolism subsequent to electroconvulsive therapy--lessons, limitations and future applications. J Affect Disord. 2008 Feb;106(1-2):203-8. doi: 10.1016/j.jad.2007.06.009. Epub 2007 Jul 26.
Results Reference
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Changes in Cerebral Glucose Metabolism After Electroconvulsive Therapy (ECT)
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