Salicylic Augmentation in Depression (SAD)

January 4, 2024 updated by: Jessica Harder

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Aspirin 325mg
Participants will take intervention drug dose once a day in combination with their existing antidepressant treatment regimen.
Other Names:
  • Aspirin
  • Bayer
  • Salicylic acid
Placebo Comparator: 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.
Drug: Placebo Oral Tablet
Participants will take a placebo tablet of the same size, shape, and color as the aspirin tablet.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hamilton Depression Scale Score
Time Frame: 8 weeks
Change in HDRS score in the treatment versus control groups.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response of Inflammatory Biomarkers
Time Frame: 2 years
Response of inflammatory biomarkers in treatment responders versus treatment non-responders at 8 weeks.
2 years
Biomarker Association With Antidepressant Response
Time Frame: 2 years
Ability to observe the degree of biomarker association with antidepressant response.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jessica Harder

Collaborators

Columbia University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2018

Primary Completion (Actual)

February 16, 2021

Study Completion (Actual)

February 16, 2021

Study Registration Dates

First Submitted

April 13, 2017

First Submitted That Met QC Criteria

May 11, 2017

First Posted (Actual)

May 15, 2017

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017P000525

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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