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Inflammation and Electroconvulsive Therapy

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02095639
Enrollment
5
Registered
2014-03-26
Start date
2012-08-31
Completion date
2017-05-31
Last updated
2018-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

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.

Interventions

None listed

Sponsors

Centre for Addiction and Mental Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in translocator protein distribution volume (TSPO Vt) measured by [18F]FEPPA PETBaseline scan and a second PET scan after an expected average time of 2.5 weeks of ECT treatmentParticipants 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

MeasureTime frameDescription
17-item Hamilton Depression Rating Scale (HDRS)Baseline and after average 2.5 weeks of ECT treatmentScores 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 BatteryBaseline and after average 2.5 to 5 weeks of ECT treatmentNeurocognitive 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 MarkersBaseline and after average 2.5 to 5 weeks of ECT treatmentTo 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026