Salicylic Augmentation in Depression
Condition: Depression; Depressive Disorder; Major Depressive Disorder; Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Intervention: Aspirin 325mg; Placebo Oral Tablet
Intervention description: Participants will take intervention drug dose once a day in combination with their existing antidepressant treatment regimen.; Participants will take a placebo tablet of the same size, shape, and color as the aspirin tablet.
Intervention MeSH terms: Aspirin; Salicylic Acid; Salicylates
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized control trial with about half of all participants receiving placebo.
Masking: Double (Participant, Investigator)
Masking description: Study team will be blinded to participant condition. Pharmacy will be responsible for providing study drug versus identical placebo to participants.
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Aspirin; Treatment; Salicylic acid; anti-inflammatory

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.
    

Eligibility 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