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Inflammation and Electroconvulsive Therapy

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ClinicalTrials.gov Identifier: NCT02095639
Recruitment Status : Terminated (The study was terminated)
First Posted : March 26, 2014
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Jeff Meyer, Centre for Addiction and Mental Health

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.

Condition or disease
Major Depressive Disorder

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.


Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Electroconvulsive Therapy Cause Neuroinflammation? An [18F]FEPPA Positron Emission Tomography Study in Treatment Resistant Depression
Actual Study Start Date : August 2012
Actual Primary Completion Date : March 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 17-item Hamilton Depression Rating Scale (HDRS) [ Time Frame: Baseline and after average 2.5 weeks of ECT treatment ]
    Scores on the 17-item HDRS will be taken at the time of the PET scan (baseline and post-ECT) to assess whether the magnitude of change in TSPO distribution volume is associated with changes in symptom severity.

  2. Neurocognitive Battery [ Time Frame: Baseline and after average 2.5 to 5 weeks of ECT treatment ]

    Neurocognitive measures will be take at baseline and post-ECT to assess whether TSPO Vt is related to neurocognitive function. Neurocognitive battery includes:

    Autobiographical Memory Interview-Short Form (AMI-SF) Rey Auditory Verbal Learning Test (RAVLT) Wisconsin Card Sorting Test Comprehensive Trail Making Test Weschler Adult Intelligence Scale-Digit Symbol Subtest Stroop Color and Word Test Brief Visuospatial Memory Test Boston Naming Test Judgement of Line Orientation Weschler Test of Adult Reading


  3. Peripheral Inflammatory Markers [ Time Frame: Baseline and after average 2.5 to 5 weeks of ECT treatment ]
    To explore whether peripheral and central inflammation are related markers of peripheral inflammation (TNF-alpha, IL-6, CRP and IL-1beta) will be measured and correlated to brain TSPO Vt.


Biospecimen Retention:   Samples With DNA
Whole blood, plasma and serum samples will be kept for analysis of genotype, peripheral inflammatory markers and protein binding.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community and tertiary care clinic
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095639


Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
Principal Investigator: Jeffrey H Meyer, MD, PhD Research Imaging Centre, Centre for Addiction and Mental Health

Responsible Party: Jeff Meyer, Program Head, Neurochemical Imaging for Mood Disorders, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT02095639     History of Changes
Other Study ID Numbers: 074-2012
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

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