Changes in Cerebral Glucose Metabolism After Electroconvulsive Therapy (ECT)

NCT ID: NCT01514435

Last Updated: 2012-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2011-07-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ECT verum group

Patients with treatment refractory depression treated with ECT

Group Type: EXPERIMENTAL

Electroconvulsive therapy

Intervention Type: DEVICE

treatment for major depression

18-Fluoro-desoxy-glucose positron emission tomography

Intervention Type: DEVICE

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

It´s a neuroimaging technique.

Interventions

Electroconvulsive therapy

treatment for major depression

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

no other names; no other names

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• addiction as a first diagnosis
• dementia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernd Reininghaus

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Medical University Graz; Department for Psychiatry

Graz, Styria, Austria

Countries

Austria

References

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.

Reference Type: BACKGROUND

PMID: 17444078 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17662472 (View on PubMed)

Other Identifiers

BRECT-2006-PET

Identifier Type: -

Identifier Source: org_study_id