Trial Outcomes & Findings for Salsalate as an Adjunctive Treatment for Patients With Schizophrenia (NCT NCT01578486)

NCT ID: NCT01578486

Last Updated: 2018-05-08

Results Overview

Positive and negative symptoms of schizophrenia will be measured by total score on all subscales of the Positive and Negative Syndrome Scale (PANSS; score range 30-210). Higher scores correspond with worse outcomes.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 17 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2018-05-08

Participant Flow

A total of 17 subjects consented and were screened, 4 of which were screen fails. The remaining 13 received the study medication.

Participant milestones

Measure	Salsalate salsalate: open-label trial of salsalate 3g/day for 12 weeks.
Overall Study STARTED	13
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Salsalate salsalate: open-label trial of salsalate 3g/day for 12 weeks.
Overall Study Physician Decision	3
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Salsalate as an Adjunctive Treatment for Patients With Schizophrenia

Baseline characteristics by cohort

Measure	Salsalate n=8 Participants salsalate: open-label trial of salsalate 3g/day for 12 weeks.
Age, Continuous	42.8 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Positive and negative symptoms of schizophrenia will be measured by total score on all subscales of the Positive and Negative Syndrome Scale (PANSS; score range 30-210). Higher scores correspond with worse outcomes.

Outcome measures

Measure	Salsalate n=8 Participants salsalate: open-label trial of salsalate 3g/day for 12 weeks.
PANSS Total Score Baseline	58.2 units on a scale Standard Deviation 11.4
PANSS Total Score Week 12	53.5 units on a scale Standard Deviation 11.9

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Negative symptoms of schizophrenia will be measured by total score on the Scale for Assessment of Negative Symptoms (SANS; score range 0-100). Higher scores correspond with worse outcomes.

Outcome measures

Measure	Salsalate n=8 Participants salsalate: open-label trial of salsalate 3g/day for 12 weeks.
SANS Total Score Baseline	33.0 units on a scale Standard Deviation 15.7
SANS Total Score Week 12	33.0 units on a scale Standard Deviation 12.9

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Improved cognition will be measured using the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) assessment. The MATRICS assessment includes a battery of tests, and the composite t-score measures cognition across 7 domains including speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. A higher score indicates better cognition.

Outcome measures

Measure	Salsalate n=8 Participants salsalate: open-label trial of salsalate 3g/day for 12 weeks.
MATRICS Composite Score Baseline	27.9 t-score Standard Deviation 11.9
MATRICS Composite Score Week 12	31.6 t-score Standard Deviation 15.2

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Subscale of Positive and Negative Syndrome Scale that specifically measures positive symptoms. The scores range from 7-49, with higher scores representing a worse outcome.

Outcome measures

Measure	Salsalate n=8 Participants salsalate: open-label trial of salsalate 3g/day for 12 weeks.
PANSS Positive Score Baseline	13.0 units on a scale Standard Deviation 5.4
PANSS Positive Score Week 12	10.9 units on a scale Standard Deviation 4.4

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Subscale of Positive and Negative Syndrome Scale that specifically measures negative symptoms. The scores range from 7-49, with higher scores representing a worse outcome.

Outcome measures

Measure	Salsalate n=8 Participants salsalate: open-label trial of salsalate 3g/day for 12 weeks.
PANSS- Negative Score Baseline	18.5 units on a scale Standard Deviation 6.5
PANSS- Negative Score Week 12	17.4 units on a scale Standard Deviation 6.1

SECONDARY outcome

Timeframe: Baseline, 12 weeks

High-sensitivity C-reactive protein (hs-CRP) will be measured in mg/L in order to detect inflammation. Higher hs-CRP values correspond to higher levels of inflammation.

Outcome measures

Measure	Salsalate n=8 Participants salsalate: open-label trial of salsalate 3g/day for 12 weeks.
Hs-CRP Baseline	3.0 mg/L Standard Error 1.2
Hs-CRP Week 12	2.0 mg/L Standard Error 1.2

SECONDARY outcome

Timeframe: Baseline,12 weeks

Tumor necrosis-alpha factor will be measured to assess inflammation levels.

Outcome measures

Measure	Salsalate n=8 Participants salsalate: open-label trial of salsalate 3g/day for 12 weeks.
TNF-alpha Baseline	8.2 pg/ml Standard Deviation 3.7
TNF-alpha Week 12	8.7 pg/ml Standard Deviation 3.6

SECONDARY outcome

Timeframe: Baseline, week 12

IL-6 (interleukin 6) is a marker used to measure inflammation.

Outcome measures

Measure	Salsalate n=8 Participants salsalate: open-label trial of salsalate 3g/day for 12 weeks.
IL-6 Baseline	2.2 pg/mL Standard Deviation 0.87
IL-6 Week 12	2.3 pg/mL Standard Deviation 1.00

Adverse Events

Salsalate

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Salsalate n=8 participants at risk salsalate: open-label trial of salsalate 3g/day for 12 weeks.
Gastrointestinal disorders Stomach/Abdominal discomfort	12.5% 1/8 • Number of events 1
General disorders Nausea/Vomiting	12.5% 1/8 • Number of events 1
General disorders Lightheadedness	12.5% 1/8 • Number of events 1
General disorders Headache	25.0% 2/8 • Number of events 2
General disorders Weakness	12.5% 1/8 • Number of events 1
General disorders Bloody urine	12.5% 1/8 • Number of events 1

Additional Information

Xiaoduo Fan, MD, MPH

UMass Medical School

Phone: 508-856-3881

Email: xiaoduo.fan@umassmed.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place