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Salicylic Augmentation in Depression (SAD)

Primary Purpose

Depression, Depressive Disorder, Major Depressive Disorder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aspirin 325mg
Placebo Oral Tablet
Sponsored by
Jessica Harder
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Aspirin, Treatment, Salicylic acid, anti-inflammatory

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Aspirin augmentation to treatment

Placebo augmentation to treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Hamilton Depression Scale score
Change in HDRS score in the treatment versus control groups.

Secondary Outcome Measures

Response of inflammatory biomarkers
Response of inflammatory biomarkers in treatment responders versus treatment non-responders at 8 weeks.
Biomarker association with antidepressant response
Ability to observe the degree of biomarker association with antidepressant response.

Full Information

First Posted
April 13, 2017
Last Updated
July 29, 2021
Sponsor
Jessica Harder
Collaborators
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT03152409
Brief Title
Salicylic Augmentation in Depression
Acronym
SAD
Official Title
Salicylic Augmentation in Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jessica Harder
Collaborators
Columbia University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Disorder, Major Depressive Disorder, Treatment Resistant Depression
Keywords
Aspirin, Treatment, Salicylic acid, anti-inflammatory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial with about half of all participants receiving placebo.
Masking
ParticipantInvestigator
Masking Description
Study team will be blinded to participant condition. Pharmacy will be responsible for providing study drug versus identical placebo to participants.
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aspirin augmentation to treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo augmentation to treatment
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aspirin 325mg
Other Intervention Name(s)
Aspirin, Bayer, Salicylic acid
Intervention Description
Participants will take intervention drug dose once a day in combination with their existing antidepressant treatment regimen.
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Other Intervention Name(s)
Placebo
Intervention Description
Participants will take a placebo tablet of the same size, shape, and color as the aspirin tablet.
Primary Outcome Measure Information:
Title
Change in Hamilton Depression Scale score
Description
Change in HDRS score in the treatment versus control groups.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Response of inflammatory biomarkers
Description
Response of inflammatory biomarkers in treatment responders versus treatment non-responders at 8 weeks.
Time Frame
2 years
Title
Biomarker association with antidepressant response
Description
Ability to observe the degree of biomarker association with antidepressant response.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Harder, MD
Phone
617-732-6753
Email
jaharder@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Harder, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Harder, MD
Phone
617-732-6753
Email
JAHARDER@PARTNERS.ORG
First Name & Middle Initial & Last Name & Degree
Jessica Harder, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20151847
Citation
Philip NS, Carpenter LL, Tyrka AR, Price LH. Pharmacologic approaches to treatment resistant depression: a re-examination for the modern era. Expert Opin Pharmacother. 2010 Apr;11(5):709-22. doi: 10.1517/14656561003614781.
Results Reference
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PubMed Identifier
23506529
Citation
Berk M, Dean O, Drexhage H, McNeil JJ, Moylan S, O'Neil A, Davey CG, Sanna L, Maes M. Aspirin: a review of its neurobiological properties and therapeutic potential for mental illness. BMC Med. 2013 Mar 18;11:74. doi: 10.1186/1741-7015-11-74.
Results Reference
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PubMed Identifier
23993259
Citation
Iyengar RL, Gandhi S, Aneja A, Thorpe K, Razzouk L, Greenberg J, Mosovich S, Farkouh ME. NSAIDs are associated with lower depression scores in patients with osteoarthritis. Am J Med. 2013 Nov;126(11):1017.e11-8. doi: 10.1016/j.amjmed.2013.02.037. Epub 2013 Aug 29.
Results Reference
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PubMed Identifier
16491133
Citation
Muller N, Schwarz MJ, Dehning S, Douhe A, Cerovecki A, Goldstein-Muller B, Spellmann I, Hetzel G, Maino K, Kleindienst N, Moller HJ, Arolt V, Riedel M. The cyclooxygenase-2 inhibitor celecoxib has therapeutic effects in major depression: results of a double-blind, randomized, placebo controlled, add-on pilot study to reboxetine. Mol Psychiatry. 2006 Jul;11(7):680-4. doi: 10.1038/sj.mp.4001805. Epub 2006 Feb 21.
Results Reference
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PubMed Identifier
25455584
Citation
Eyre HA, Air T, Proctor S, Rositano S, Baune BT. A critical review of the efficacy of non-steroidal anti-inflammatory drugs in depression. Prog Neuropsychopharmacol Biol Psychiatry. 2015 Mar 3;57:11-6. doi: 10.1016/j.pnpbp.2014.10.003. Epub 2014 Oct 16.
Results Reference
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PubMed Identifier
23032386
Citation
Gallagher PJ, Castro V, Fava M, Weilburg JB, Murphy SN, Gainer VS, Churchill SE, Kohane IS, Iosifescu DV, Smoller JW, Perlis RH. Antidepressant response in patients with major depression exposed to NSAIDs: a pharmacovigilance study. Am J Psychiatry. 2012 Oct;169(10):1065-72. doi: 10.1176/appi.ajp.2012.11091325.
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PubMed Identifier
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Citation
Akhondzadeh S, Jafari S, Raisi F, Nasehi AA, Ghoreishi A, Salehi B, Mohebbi-Rasa S, Raznahan M, Kamalipour A. Clinical trial of adjunctive celecoxib treatment in patients with major depression: a double blind and placebo controlled trial. Depress Anxiety. 2009;26(7):607-11. doi: 10.1002/da.20589.
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Citation
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Results Reference
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Salicylic Augmentation in Depression

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