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Clinical Trials/NCT02095639
NCT02095639
Terminated
Not Applicable

Does Electroconvulsive Therapy Cause Neuroinflammation? An [18F]FEPPA Positron Emission Tomography Study in Treatment Resistant Depression

Centre for Addiction and Mental Health1 site in 1 country5 target enrollmentAugust 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
Centre for Addiction and Mental Health
Enrollment
5
Locations
1
Primary Endpoint
Change in translocator protein distribution volume (TSPO Vt) measured by [18F]FEPPA PET
Status
Terminated
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this study is to explore whether electroconvulsive therapy (ECT) accidentally leads to a side effect of brain inflammation. Patients with treatment resistant depression who are planning to take ECT will be subsequently approached to participate in the study.

Detailed Description

The first scan will take place before the first ECT session. The second scan will occur after a minimum of six ECT sessions (average 2.5 weeks). Secondary measures will include mood symptom severity, neurocognitive measures, peripheral inflammatory markers and TSPO genotype. The hypothesis is that neuroinflammation will be increased by ECT. There will be no alterations to standard care of depressed patients due to participation in the study.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
May 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeff Meyer

Program Head, Neurochemical Imaging for Mood Disorders

Centre for Addiction and Mental Health

Eligibility Criteria

Inclusion Criteria

  • stable physical health
  • diagnosis of non-psychotic, non-catatonic, major depressive disorder, either unipolar or bipolar and a non-response to at least three clinical trials at appropriate dose of antidepressant medication from at least three different pharmacological classes
  • at least a 17 on the17-item HDRS despite taking antidepressant treatment prior to ECT
  • have not received ECT within the last 12 weeks

Exclusion Criteria

  • currently pregnant
  • current substance abuse or dependence
  • neurological or unstable medical illness
  • use of anti-inflammatory drugs within the past month
  • diazepam or other benzodiazepine use within the past month, except for lorazepam and clonazepam

Outcomes

Primary Outcomes

Change in translocator protein distribution volume (TSPO Vt) measured by [18F]FEPPA PET

Time Frame: Baseline scan and a second PET scan after an expected average time of 2.5 weeks of ECT treatment

Participants will have one \[18F\]FEPPA PET scan before they start ECT and a second PET scan on average after 2.5 weeks of ECT

Secondary Outcomes

  • 17-item Hamilton Depression Rating Scale (HDRS)(Baseline and after average 2.5 weeks of ECT treatment)
  • Neurocognitive Battery(Baseline and after average 2.5 to 5 weeks of ECT treatment)
  • Peripheral Inflammatory Markers(Baseline and after average 2.5 to 5 weeks of ECT treatment)

Study Sites (1)

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