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Changes in Cerebral Glucose Metabolism After Electroconvulsive Therapy (ECT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01514435
First received: January 11, 2012
Last updated: January 17, 2012
Last verified: January 2012

January 11, 2012
January 17, 2012
May 2006
May 2009   (final data collection date for primary outcome measure)
Brain glucose metabolism measured by FDG-PET [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01514435 on ClinicalTrials.gov Archive Site
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Changes in Cerebral Glucose Metabolism After Electroconvulsive Therapy (ECT)
Clinical Effects of Electroconvulsive Therapy in Severe Depression and Concomitant Changes in Cerebral Glucose Metabolism - an Exploratory Study

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.

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Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
  • Device: Electroconvulsive therapy
    treatment for major depression
    Other Name: no other names
  • Device: 18-Fluoro-desoxy-glucose positron emission tomography

    intravenous injection of 18-FDG, after 30 min PET-Scan of the brain for aprox. 40 min.

    It´s a neuroimaging technique.

    Other Name: no other names
Experimental: ECT verum group
Patients with treatment refractory depression treated with ECT
Interventions:
  • Device: Electroconvulsive therapy
  • Device: 18-Fluoro-desoxy-glucose positron emission tomography

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
July 2011
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • clinical indication for ECT
  • treatment refractory depressive episode
  • age 18-85 y

Exclusion Criteria:

  • addiction as a first diagnosis
  • dementia
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01514435
BRECT-2006-PET
No
Medical University of Graz
Medical University of Graz
Not Provided
Principal Investigator: Bernd Reininghaus Medical University of Graz
Medical University of Graz
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP