Salicylic Augmentation in Depression

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2021-02-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depression Depressive Disorder Major Depressive Disorder Treatment Resistant Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial with about half of all participants receiving placebo.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study team will be blinded to participant condition. Pharmacy will be responsible for providing study drug versus identical placebo to participants.

Study Groups

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Aspirin augmentation to treatment

Participants who meet inclusion criteria for the study and are randomized to the active treatment arm will be given pills for the ensuing 8 weeks, consisting of a daily dose of aspirin 325 mg to be taken every evening before bed.

Group Type ACTIVE_COMPARATOR

Aspirin 325mg

Intervention Type DRUG

Participants will take intervention drug dose once a day in combination with their existing antidepressant treatment regimen.

Placebo augmentation to treatment

Participants randomized to the placebo arm will receive a placebo oral tablet of the same size, shape, and color as the aspirin tablet. Participants will be instructed to take their pills in the evening before bed.

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Participants will take a placebo tablet of the same size, shape, and color as the aspirin tablet.

Interventions

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Aspirin 325mg

Participants will take intervention drug dose once a day in combination with their existing antidepressant treatment regimen.

Intervention Type DRUG

Placebo Oral Tablet

Participants will take a placebo tablet of the same size, shape, and color as the aspirin tablet.

Intervention Type DRUG

Other Intervention Names

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Aspirin Bayer Salicylic acid Placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No