Inflammation and Electroconvulsive Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02095639|
Recruitment Status : Terminated (The study was terminated)
First Posted : March 26, 2014
Last Update Posted : February 14, 2018
|Condition or disease|
|Major Depressive Disorder|
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|
|Official Title:||Does Electroconvulsive Therapy Cause Neuroinflammation? An [18F]FEPPA Positron Emission Tomography Study in Treatment Resistant Depression|
|Actual Study Start Date :||August 2012|
|Primary Completion Date :||March 2017|
|Study Completion Date :||May 2017|
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.
- 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
- 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.
- 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
- 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
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
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada, M5T 1R8|
|Principal Investigator:||Jeffrey H Meyer, MD, PhD||Research Imaging Centre, Centre for Addiction and Mental Health|