Trial Outcomes & Findings for Salicylic Augmentation in Depression (NCT NCT03152409)

NCT ID: NCT03152409

Last Updated: 2024-01-31

Results Overview

Change in HDRS score in the treatment versus control groups.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

8 weeks

Results posted on

2024-01-31

Participant Flow

After completing informed consent, participants who agreed to participate in the study began study procedures; those with a positive pregnancy test, significant abnormalities in blood counts, electrolytes, kidney function, or thyroid stimulating hormone levels, major psychiatric comorbidities, severe current active suicidality, or certain medical conditions were not eligible to be randomized and were excluded prior to group assignment.

Participant milestones

Participant milestones
Measure	Aspirin Augmentation to Treatment Daily dose of aspirin 325 mg in combination with their existing antidepressant treatment regimen.	Placebo Augmentation to Treatment Daily placebo oral tablet of the same size, shape, and color as the aspirin tablet in combination with their existing antidepressant treatment regimen.
Overall Study STARTED	6	5
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Salicylic Augmentation in Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aspirin Augmentation to Treatment n=6 Participants Daily dose of aspirin 325 mg in combination with their existing antidepressant treatment regimen.	Placebo Augmentation to Treatment n=5 Participants Daily dose of placebo in combination with their existing antidepressant treatment regimen.	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants
Hamilton Depression Rating Scale (HDRS) Score	20.5 units on a scale n=5 Participants	21.4 units on a scale n=7 Participants	20.9 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Analysis population consisted of study completers for whom HDRS scores from final study visit were available.

Change in HDRS score in the treatment versus control groups.

Outcome measures

Outcome measures
Measure	Aspirin Augmentation to Treatment n=4 Participants Daily dose of aspirin 325 mg in combination with their existing antidepressant treatment regimen.	Placebo Augmentation to Treatment n=3 Participants Daily dose of placebo in combination with their existing antidepressant treatment regimen.
Change in Hamilton Depression Scale Score	-9.75 units on a scale Interval -16.0 to 5.0	-11.67 units on a scale Interval -21.0 to -7.0

SECONDARY outcome

Timeframe: 2 years

Population: No participant inflammatory data were collected. Although blood samples were collected for planned inflammatory assays, the samples were frozen and assays were never performed. Once study was terminated prematurely (due to lack of resources) no further funds were allocated to the study. Thus inflammatory assays could not be funded and inflammatory data analysis could not proceed.

Response of inflammatory biomarkers in treatment responders versus treatment non-responders at 8 weeks.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Unable to analyze biomarker association with antidepressant response as there was no biomarker data to analyze (study was terminated due to insufficient resources to continue, and biomarker assays were thus never completed).

Ability to observe the degree of biomarker association with antidepressant response.

Outcome measures

Outcome data not reported

Adverse Events

Aspirin Augmentation to Treatment

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo Augmentation to Treatment

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aspirin Augmentation to Treatment n=6 participants at risk Daily dose of aspirin 325 mg in combination with their existing antidepressant treatment regimen.	Placebo Augmentation to Treatment n=5 participants at risk Daily dose of placebo in combination with their existing antidepressant treatment regimen.
Renal and urinary disorders Urinary tract infection	16.7% 1/6 • Number of events 1 • 8 weeks	0.00% 0/5 • 8 weeks
Injury, poisoning and procedural complications Bone fracture	16.7% 1/6 • Number of events 1 • 8 weeks	0.00% 0/5 • 8 weeks
Psychiatric disorders Symptoms of existing major depression	16.7% 1/6 • Number of events 1 • 8 weeks	40.0% 2/5 • Number of events 3 • 8 weeks

Other adverse events

Other adverse events
Measure	Aspirin Augmentation to Treatment n=6 participants at risk Daily dose of aspirin 325 mg in combination with their existing antidepressant treatment regimen.	Placebo Augmentation to Treatment n=5 participants at risk Daily dose of placebo in combination with their existing antidepressant treatment regimen.
Skin and subcutaneous tissue disorders Itchiness	0.00% 0/6 • 8 weeks	20.0% 1/5 • Number of events 1 • 8 weeks
Reproductive system and breast disorders Menstrual symptoms	33.3% 2/6 • 8 weeks	20.0% 1/5 • 8 weeks
Nervous system disorders Headache	16.7% 1/6 • 8 weeks	20.0% 1/5 • 8 weeks
General disorders Dental / oral problems	16.7% 1/6 • 8 weeks	40.0% 2/5 • 8 weeks
Gastrointestinal disorders GI discomfort or distress	16.7% 1/6 • 8 weeks	20.0% 1/5 • 8 weeks
Infections and infestations Upper respiratory tract infection symptoms	16.7% 1/6 • 8 weeks	20.0% 1/5 • 8 weeks
Respiratory, thoracic and mediastinal disorders Shortness of breath	16.7% 1/6 • 8 weeks	20.0% 1/5 • 8 weeks
Renal and urinary disorders Urinary tract symptoms	16.7% 1/6 • 8 weeks	0.00% 0/5 • 8 weeks
Psychiatric disorders Depression and related symptoms	16.7% 1/6 • 8 weeks	40.0% 2/5 • 8 weeks
General disorders Muscle aches	16.7% 1/6 • 8 weeks	20.0% 1/5 • 8 weeks
General disorders Dizziness	16.7% 1/6 • 8 weeks	0.00% 0/5 • 8 weeks
Cardiac disorders Rapid heart rate	16.7% 1/6 • 8 weeks	0.00% 0/5 • 8 weeks
Nervous system disorders Paresthesia	0.00% 0/6 • 8 weeks	20.0% 1/5 • 8 weeks

Additional Information

Dr. Jessica Harder

Brigham and Women's Hospital

Phone: 6177326753

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place