RECRUITING

Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab

Conditions

Depressive Disorder, Major Inflammation Depression Major Depressive Disorder Infliximab Cognitive Dysfunction

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a mechanistic randomized controlled trial that investigates whether inhibition of tumor necrosis factor signaling via intravenous infusion of infliximab improves psychomotor speed and executive functioning in depressed individuals who exhibit an inflammatory phenotype.

Official Title

The Role of Inflammation in Cognitive Dysfunction in Acute Depression as Determined by Experimental Inhibition of Tumor Necrosis Factor-alpha Signaling in a Randomized Controlled Trial.

Quick Facts

Study Start:2024-12-13

Study Completion:2029-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06136546

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Aged 25-50 years 2. Able to read and understand English and willing to provide informed consent/comply with the study protocol 3. Willingness to complete intravenous infusion and have blood drawn 4. Exhibit circulating blood level of C reactive protein ≥ 3mg/L 5. Diagnosed with Major Depressive Disorder 6. Moderate depressive symptom severity, as indicated by score ≥15 on the Hamilton Depression Rating Scale 7. Antidepressant treatment free for at least 4 weeks prior to study entry or be on a fixed treatment regimen for at least 4 weeks; willingness to continue treatment status (i.e., change/begin new treatment) until study termination 8. Willingness not to begin/change therapies until study termination (maximum of three weeks following screening) 9. Be of non-childbearing potential per the following specific criteria:	1. Medical conditions that could confound interpretation or increase participant risk, as indicated via medical history or laboratory testing; exclusionary medical conditions will include: 2. Active antipsychotic and anticonvulsant medication use (that interact with infliximab) 3. Prior use of a TNF antagonist or use of systemic corticosteroids or anti-proliferative agents within one year of study entry 4. History of liver abnormalities 5. Major cognitive impairment as determined by study investigators 6. Active restrictive eating disorder or obsessive compulsive disorder deemed by study investigators to be primary cause of depressive disorder 7. History of a psychotic disorder or Bipolar disorder type I/II 8. Current substance use disorder (i.e., present in last six months), of greater than mild severity 9. Suicidal ideation based on a score ≥3 on the Columbia-Suicide Severity Rating Scale 10. Electroconvulsive therapy (ECT)/deep brain stimulation (DBS) within the last year, or report of persistent negative cognitive effects of ECT/DBS 11. Presence of a transplanted solid organ 12. Medication use affecting immune or cognitive function: 13. Considered by the study investigators to be inappropriate for the study due to safety concerns or to be unlikely to complete the protocol 14. History of allergic response to murine products

Inclusion Criteria

Exclusion Criteria

1. Aged 25-50 years
2. Able to read and understand English and willing to provide informed consent/comply with the study protocol
3. Willingness to complete intravenous infusion and have blood drawn
4. Exhibit circulating blood level of C reactive protein ≥ 3mg/L
5. Diagnosed with Major Depressive Disorder
6. Moderate depressive symptom severity, as indicated by score ≥15 on the Hamilton Depression Rating Scale
7. Antidepressant treatment free for at least 4 weeks prior to study entry or be on a fixed treatment regimen for at least 4 weeks; willingness to continue treatment status (i.e., change/begin new treatment) until study termination
8. Willingness not to begin/change therapies until study termination (maximum of three weeks following screening)
9. Be of non-childbearing potential per the following specific criteria:

1. Medical conditions that could confound interpretation or increase participant risk, as indicated via medical history or laboratory testing; exclusionary medical conditions will include:
2. Active antipsychotic and anticonvulsant medication use (that interact with infliximab)
3. Prior use of a TNF antagonist or use of systemic corticosteroids or anti-proliferative agents within one year of study entry
4. History of liver abnormalities
5. Major cognitive impairment as determined by study investigators
6. Active restrictive eating disorder or obsessive compulsive disorder deemed by study investigators to be primary cause of depressive disorder
7. History of a psychotic disorder or Bipolar disorder type I/II
8. Current substance use disorder (i.e., present in last six months), of greater than mild severity
9. Suicidal ideation based on a score ≥3 on the Columbia-Suicide Severity Rating Scale
10. Electroconvulsive therapy (ECT)/deep brain stimulation (DBS) within the last year, or report of persistent negative cognitive effects of ECT/DBS
11. Presence of a transplanted solid organ
12. Medication use affecting immune or cognitive function:
13. Considered by the study investigators to be inappropriate for the study due to safety concerns or to be unlikely to complete the protocol
14. History of allergic response to murine products

Contacts and Locations

Study Contact

Naoise Mac Giollabhui, PhD

CONTACT

6177241000

nmacgiollabhui@mgh.harvard.edu

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-13

Study Completion Date2029-01-31

Study Record Updates

Study Start Date2024-12-13

Study Completion Date2029-01-31

Terms related to this study

Keywords Provided by Researchers

Depression
Major Depressive Disorder
Infliximab
Cognitive Dysfunction

Additional Relevant MeSH Terms

Depressive Disorder, Major
Inflammation