Inflammation and Electroconvulsive Therapy

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02095639
• Other study ID #: 074-2012
• Status: Terminated
• Phase: N/A
• First received: March 20, 2014
• Last updated: February 13, 2018
• Start date: August 2012
• Est. completion date: May 2017

Study information

• Verified date: February 2018
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in translocator protein distribution volume (TSPO Vt) measured by [18F]FEPPA PET	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	Baseline scan and a second PET scan after an expected average time of 2.5 weeks of ECT treatment
Secondary	17-item Hamilton Depression Rating Scale (HDRS)	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.	Baseline and after average 2.5 weeks of ECT treatment
Secondary	Neurocognitive Battery	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	Baseline and after average 2.5 to 5 weeks of ECT treatment
Secondary	Peripheral Inflammatory Markers	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.	Baseline and after average 2.5 to 5 weeks of ECT treatment