NCT01514435

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2012

Completed
Last Updated

January 23, 2012

Status Verified

January 1, 2012

Enrollment Period

3 years

First QC Date

January 11, 2012

Last Update Submit

January 17, 2012

Conditions

Keywords

depressionFDG-PETElectroconvulsive therapyglucose metabolism

Outcome Measures

Primary Outcomes (1)

  • Brain glucose metabolism measured by FDG-PET

    one year

Study Arms (1)

ECT verum group

EXPERIMENTAL

Patients with treatment refractory depression treated with ECT

Device: Electroconvulsive therapyDevice: 18-Fluoro-desoxy-glucose positron emission tomography

Interventions

treatment for major depression

Also known as: no other names
ECT verum group

intravenous injection of 18-FDG, after 30 min PET-Scan of the brain for aprox. 40 min. It´s a neuroimaging technique.

Also known as: no other names
ECT verum group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • addiction as a first diagnosis
  • dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Graz; Department for Psychiatry

Graz, Styria, 8036, Austria

Location

Related Publications (2)

  • 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.

    PMID: 17444078BACKGROUND
  • 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.

    PMID: 17662472BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Bernd Reininghaus

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2012

First Posted

January 23, 2012

Study Start

May 1, 2006

Primary Completion

May 1, 2009

Study Completion

July 1, 2011

Last Updated

January 23, 2012

Record last verified: 2012-01

Locations