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
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|
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 (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|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.|
|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|
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.
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
- Change in Hamilton Depression Scale score [ Time Frame: 8 weeks ]Change in HDRS score in the treatment versus control groups.
- Response of inflammatory biomarkers [ Time Frame: 2 years ]Response of inflammatory biomarkers in treatment responders versus treatment non-responders at 8 weeks.
- Biomarker association with antidepressant response [ Time Frame: 2 years ]Ability to observe the degree of biomarker association with antidepressant response.
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
|Contact: Jessica Harder, MDfirstname.lastname@example.org|
|Contact: Brittany Gluskinemail@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Jessica Harder, MD|
|Principal Investigator:||Jessica Harder, MD||Brigham and Women's Hospital|