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
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Device: Electroconvulsive therapy
Device: 18-Fluoro-desoxy-glucose positron emission tomography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Effects of Electroconvulsive Therapy in Severe Depression and Concomitant Changes in Cerebral Glucose Metabolism - an Exploratory Study

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Brain glucose metabolism measured by FDG-PET [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: May 2006
Study Completion Date: July 2011
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ECT verum group
Patients with treatment refractory depression treated with ECT
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • addiction as a first diagnosis
  • dementia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514435

Locations
Austria
Medical University Graz; Department for Psychiatry
Graz, Styria, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Bernd Reininghaus Medical University of Graz
  More Information

Publications:
Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01514435     History of Changes
Other Study ID Numbers: BRECT-2006-PET
Study First Received: January 11, 2012
Last Updated: January 17, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
depression
FDG-PET
Electroconvulsive therapy
glucose metabolism

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 29, 2014