Boston, Massachusetts 02115

  • Treatment Resistant Depression

Purpose:

The investigators are doing this research study to find out if using aspirin along with antidepressant treatment can lessen symptoms of depression. This study also aims to find out if some people improve more from taking aspirin than others. The investigators also want to see if it is possible to predict which participants will do better based on a blood test. Aspirin is approved by the U.S. Food and Drug Administration (FDA) as an over-the-counter pain medication. But, aspirin is not approved by the FDA to make antidepressant treatment better. This research study will compare aspirin to placebo.


Study summary:

This study is a randomized, double-blind, placebo-control trial. The primary aims of this study are: Aim 1: To evaluate the clinical effect of aspirin augmentation on depression. Aim 2: To assess the inflammatory profile of the blood of the aspirin augmentation responders compared with the non-responders. Aim 3: To evaluate whether immune gene expression patterns are associated with antidepressant response to aspirin. Aim 4: To collect samples for later, more detailed immunologic characterization.


Criteria:

Inclusion Criteria: - Current diagnosis of major depressive disorder - Hamilton Depression Rating Scale (HDRS) score of >19 - Stable treatment regimen (no medication changes or changes in psychotherapy treatment in past 8 weeks, and no participation in stepped treatments, such as completion of a course of cognitive behavioral therapy, during the trial) - Failed to remit with at least 1 antidepressant trial, or combination of 1 antidepressant and 1 augmentation agent - Women of childbearing age must agree to use an approved method of contraception for the duration of the study Exclusion Criteria: - Active suicidal ideation - History of manic episodes or psychosis - Alcohol or substance use disorder up to one month prior to first testing session - Comorbid neurologic condition affecting the central nervous system - Comorbid autoimmune condition - Uncorrected thyroid disease or a current abnormal thyroid-stimulating hormone (TSH) - Active or recent (within the past month) infection (such as otitis, pneumonia, urinary tract infection); temperature > 100.3 or white blood cell (WBC) count > 11 K/microL will be considered evidence of active infection even in the absence of other symptoms - History of GI bleed - History of stroke - History of a bleeding disorder - Platelet count < 150,000/mm3 on initial screening - On a blood-thinning agent or taking NSAIDs daily - Current use of oral steroids or other immunomodulating medications - Salicylate sensitivity - Pregnancy or breastfeeding


NCT ID:

NCT03152409


Primary Contact:

Principal Investigator
Jessica Harder, MD
Brigham and Women's Hospital

Jessica Harder, MD
Phone: 617-732-6753
Email: jaharder@partners.org


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02115
United States

Jessica Harder, MD
Phone: 617-732-6753
Email: JAHARDER@PARTNERS.ORG

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 28, 2022

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