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Salicylic Augmentation in Depression (SAD)

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ClinicalTrials.gov Identifier: NCT03152409
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : February 18, 2019
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Jessica Harder, Brigham and Women's Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Depression Depressive Disorder Major Depressive Disorder Treatment Resistant Depression Drug: Aspirin 325mg Drug: Placebo Oral Tablet Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
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.
Primary Purpose: Treatment
Official Title: Salicylic Augmentation in Depression
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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 Name: Placebo




Primary Outcome Measures :
  1. Change in Hamilton Depression Scale score [ Time Frame: 8 weeks ]
    Change in HDRS score in the treatment versus control groups.


Secondary Outcome Measures :
  1. Response of inflammatory biomarkers [ Time Frame: 2 years ]
    Response of inflammatory biomarkers in treatment responders versus treatment non-responders at 8 weeks.

  2. Biomarker association with antidepressant response [ Time Frame: 2 years ]
    Ability to observe the degree of biomarker association with antidepressant response.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152409


Contacts
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Contact: Jessica Harder, MD 617-732-6753 jaharder@partners.org
Contact: Brittany Gluskin 857-307-1290 bgluskin@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jessica Harder, MD    617-732-6753    JAHARDER@PARTNERS.ORG   
Contact: Brittany Gluskin    857-307-1290    bgluskin@bwh.harvard.edu   
Principal Investigator: Jessica Harder, MD         
Sponsors and Collaborators
Jessica Harder
Columbia University
Investigators
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Principal Investigator: Jessica Harder, MD Brigham and Women's Hospital

Publications:

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Responsible Party: Jessica Harder, Principle Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03152409     History of Changes
Other Study ID Numbers: 2017P000525
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Jessica Harder, Brigham and Women's Hospital:
Aspirin
Treatment
Salicylic acid
anti-inflammatory

Additional relevant MeSH terms:
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Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Aspirin
Salicylates
Salicylic Acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents