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Salicylic Augmentation for Depression (SAD Trial)

Phase 2
Waitlist Available
Led By Jessica Harder, MD
Research Sponsored by Jessica Harder
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

SAD Trial Summary

This trial will test if adding aspirin to antidepressants can help lessen symptoms of depression and if certain people may benefit more than others.

Eligible Conditions
  • Depression
  • Major Depressive Disorder

SAD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Hamilton Depression Scale Score
Secondary outcome measures
Biomarker Association With Antidepressant Response
Response of Inflammatory Biomarkers

SAD Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Aspirin augmentation to treatmentActive Control1 Intervention
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 II: Placebo augmentation to treatmentPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Jessica HarderLead Sponsor
Columbia UniversityOTHER
1,429 Previous Clinical Trials
2,460,120 Total Patients Enrolled
46 Trials studying Depression
37,521 Patients Enrolled for Depression
Jessica Harder, MDPrincipal Investigator - Brigham and Women's Hospital
Brigham & Women's Faulkner Hospital, Brigham & Women's Hospital
Cornell University Medical College (Residency)
2 Previous Clinical Trials
24 Total Patients Enrolled
2 Trials studying Depression
24 Patients Enrolled for Depression

Media Library

Placebo Oral Tablet Clinical Trial Eligibility Overview. Trial Name: NCT03152409 — Phase 2
Depression Research Study Groups: Placebo augmentation to treatment, Aspirin augmentation to treatment
Depression Clinical Trial 2023: Placebo Oral Tablet Highlights & Side Effects. Trial Name: NCT03152409 — Phase 2
Placebo Oral Tablet 2023 Treatment Timeline for Medical Study. Trial Name: NCT03152409 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

When is Aspirin augmentation to treatment most effective?

"By augmenting traditional treatments with Aspirin, it is possible to effectively manage pain, dermatitis, and myocardial infarction."

Answered by AI

Are patients of all ages eligible for this experiment?

"The clinical trial's eligibility requirements state that patients must be aged 18-65. There are currently 443 trials underway for minors and 1673 separate trials being conducted with elderly patients."

Answered by AI

Are people currently being accepted into this test program?

"The trial, which was first advertised on November 15th 2018, is looking for volunteers according to the latest information available from clinicaltrials.gov. The site was last updated on July 29th 2021."

Answered by AI

To what degree does Aspirin improve patient outcomes when used in conjunction with other treatments?

"While there is some evidence that Aspirin augmentation to treatment is safe, it remains unproven if the intervention is effective. Our team has rated its safety a 2."

Answered by AI

Who would be most benefited by participating in this clinical trial?

"Up to 74 individuals that are experiencing melancholia and meet the age requirement of 18-65 years old may be admitted into this study. The key inclusion criteria are as follows: a stable treatment history in the past 8 weeks with no changes in medication or psychotherapy, women of childbearing age must agree to use contraception during the trial, a current diagnosis of major depressive disorder, an HDRS score >19, failed antidepressant trials in the past, or a combination of 1 antidepressant and 1 augmentation agent."

Answered by AI

Has there been any research like this before?

"As of right now, there are 182 independent Aspirin augmentation to treatment trials being conducted in 61 countries and 1451 cities. The very first trial was all the way back in 2002 and it completed its Phase 3 drug approval stage that year. Since then, 689 more studies have been finished."

Answered by AI
Recent research and studies
~5 spots leftby Apr 2025