Salicylic Augmentation in Depression

  • STATUS
    Recruiting
  • End date
    Dec 10, 2023
  • participants needed
    74
  • sponsor
    Jessica Harder
Updated on 10 August 2021
blood tests
depression
behavior therapy
blood test
behavioral therapy
depressive disorder
antidepressants
depressive symptoms
depressed mood
cognitive therapy
psychotherapy
major depressive disorder
behavior modification
hdrs
aspirin 325 mg

Summary

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.

Description

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.

Details
Condition mood disorder, Major depression, Endogenous depression, Depression, Depression (Major/Severe), Depression (Adolescent), Depression (Pediatric), Depression (Adult and Geriatric), Depression (Treatment-Resistant), Treatment Resistant Depression, Depressed, Mood Disorders (Pediatric), Affective Disorders, Mood Disorders, depressive disorder, major depressive disorder, major depressive disorders, depressed mood, miserable, depressive disorders
Treatment Placebo Oral Tablet, Aspirin 325mg
Clinical Study IdentifierNCT03152409
SponsorJessica Harder
Last Modified on10 August 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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