Inflammation and Electroconvulsive Therapy

Terminated

• Conditions: Major Depressive Disorder

• Registration Number: NCT02095639
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-08
• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-26
• Primary Completion: 2017-03
• Study Completion: 2017-05
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Name	Time	Method
17-item Hamilton Depression Rating Scale (HDRS)	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.
Neurocognitive Battery	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
Peripheral Inflammatory Markers	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.

Trial Locations

Locations (1)

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada