Salicylic Augmentation in Depression

Phase 2TerminatedNCT03152409

Jessica Harder32 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Depression Depressive Disorder

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Hamilton Depression Scale Score

Change in HDRS score in the treatment versus control groups.

Time frame: 8 weeks

Secondary Outcomes

Response of Inflammatory Biomarkers

Response of inflammatory biomarkers in treatment responders versus treatment non-responders at 8 weeks.

Time frame: 2 years

Biomarker Association With Antidepressant Response

Ability to observe the degree of biomarker association with antidepressant response.