Salsalate as an Adjunctive Treatment for Patients With Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- SANS Total Score
研究概览
简要总结
This is a 12-week, open-label trial of salsalate 3 g/day as an adjunctive treatment in 15 schizophrenia subjects to examine salsalate's effect on psychopathology, cognitive functioning, and metabolic parameters.
Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or Massachusetts General Hospital. A total of 15 subjects will be enrolled.
详细描述
The specific aims include:
Primary aims:
- Examine the efficacy of salsalate (3g/day) in improving positive and negative symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) and the Scale for Assessment of Negative Symptoms (SANS).
- Examine the efficacy of salsalate in improving cognition as measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) composite score.
Secondary aims:
- Examine salsalate's effects on inflammatory markers such as high sensitivity C-reactive protein (hs-CRP), TNF-α and IL-6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years;
- •Diagnosis of schizophrenia or schizoaffective disorder;
- •Stable dose of the current antipsychotic drug for at least one month;
- •Well established compliance with outpatient treatment per treating clinician's judgment;
- •Able to complete the cognitive assessment battery (must be English speaking);
- •Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study.
排除标准
- •Inability to provide informed consent;
- •Current substance abuse;
- •Psychiatrically unstable per treating clinician's judgment;
- •Significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases;
- •Currently on immunosuppressant medication including oral steroids;
- •Use of anti-coagulants (heparin, LMWH, warfarin, cilostazol, clopidogrel, dabigatran);
- •History of chronic infection (including, HIV and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition;
- •Experienced asthma, urticaria or allergic type reaction after taking aspirin, salsalate, or other NSAIDS;
- •Pregnancy or breastfeeding;
- •Pre-existing chronic tinnitus.
- •Known hypersensitivity to salsalate.
研究组 & 干预措施
salsalate
open-label trial of salsalate 3g/day
干预措施: salsalate (Drug)
结局指标
主要结局
SANS Total Score
时间窗: 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.
MATRICS Composite Score
时间窗: 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.
PANSS Total Score
时间窗: 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.
PANSS Positive Score
时间窗: 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.
PANSS- Negative Score
时间窗: 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.
次要结局
- Hs-CRP(Baseline, 12 weeks)
- TNF-alpha(Baseline,12 weeks)
- IL-6(Baseline, week 12)
研究者
Xiaoduo Fan
Principal Investigator
University of Massachusetts, Worcester