Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab

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.

Conditions

Depressive Disorder, Major, Inflammation

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Study Overview

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Study Details

Study overview

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.

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.

Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab

Condition
Depressive Disorder, Major
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

25 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Study Record Dates

2029-01-31