Trials / Terminated
TerminatedNCT03152409
Salicylic Augmentation in Depression
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Jessica Harder · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aspirin 325mg | Participants will take intervention drug dose once a day in combination with their existing antidepressant treatment regimen. |
| DRUG | Placebo Oral Tablet | Participants will take a placebo tablet of the same size, shape, and color as the aspirin tablet. |
Timeline
- Start date
- 2018-11-15
- Primary completion
- 2021-02-16
- Completion
- 2021-02-16
- First posted
- 2017-05-15
- Last updated
- 2024-01-31
- Results posted
- 2024-01-31
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03152409. Inclusion in this directory is not an endorsement.