Inflammation and Electroconvulsive Therapy

NCT ID: NCT02095639

Last Updated: 2018-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2017-05-31

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ECT and Treatment Resistant Depression

Subjects will be those with diagnosis of major depressive disorder that have not responded to many different treatments and who are planning to take electroconvulsive therapy (ECT). This group will receive two \[18F\]FEPPA PET scans, one baseline and one after an average of 2.5 weeks of ECT treatments.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre for Addiction and Mental Health

OTHER

Sponsor Role lead

Responsible Party

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Jeff Meyer

Program Head, Neurochemical Imaging for Mood Disorders

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey H Meyer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Imaging Centre, Centre for Addiction and Mental Health

Locations

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Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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074-2012

Identifier Type: -

Identifier Source: org_study_id

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