A Pilot Open-label Trial of Pentosan Polysulfate Sodium and Meclofenamic Acid As Adjunctive Treatments in Patients With Psychotic Disorders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery (NCTB) Composite Score
研究概览
简要总结
This study evaluates the feasibility of administering meclofenamic acid or pentosan polysulfate sodium as an adjunctive treatment to patients diagnosed with a psychotic disorder. Half of participants will receive meclofenamic acid, while the other half will receive polysulfate sodium.
详细描述
Chronic, low-grade brain inflammation is involved in the development of schizophrenia and other psychotic disorders. Medications with anti-inflammatory properties, like meclofenamic acid and pentosan polysulfate may help to reduce brain inflammation and serve as a treatment of psychotic disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, delusional disorder, other specified schizophrenia spectrum and other psychotic disorders, unspecified schizophrenia spectrum and other psychotic disorders
- •Negative pregnancy test in females of childbearing age
排除标准
- •Urine drug screen positive for psychostimulants such as cocaine, amphetamines and ecstasy
- •Any infection, neoplasm, autoimmune disease or other primary inflammatory condition (3) Previous diagnosis of intellectual disability or dementia
- •Current treatment with heparin
- •Use of or allergy to non-steroidal anti-inflammatory agent or pentosan polysulfate sodium
- •Current or anticipated corticosteroid use
- •History of peptic ulcer disease, gastro esophageal reflux disease, or gastrointestinal bleeding
- •Those on warfarin or any anticoagulant
- •Current treatment with lithium or asthma medication
- •Individuals with pre-existing liver, cardiac, or kidney disease
研究组 & 干预措施
Meclofenamic acid
150mg meclofenamic acid daily for 8 weeks
干预措施: Meclofenamic acid (Drug)
Pentosan polysulfate sodium
300mg of pentosan polysulfate sodium daily for 8 weeks
干预措施: Pentosan polysulfate sodium (Drug)
结局指标
主要结局
Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery (NCTB) Composite Score
时间窗: baseline, 8 weeks
A higher composite score on the NCTB indicates better cognitive performance. The NCTB consists of 7 tests and 8 sub-scores, and the NIH Toolbox software calculates total composite score by averaging the normalized scores of each subscale and then deriving scale scores. The "NIH Toolbox Scoring and Interpretation Guide" (found online) doesn't indicate a total composite score range (because the score ranges are infinite), but describes scoring as follows: To get a normalized composite score, the score of the test taker is compared to the scores in the NIH Toolbox nationally representative normative sample. The mean score is 100 and the standard deviation (SD) is 15. A score at or near 100 indicates average ability compared with others. Scores around 115 suggest above-average ability. Scores around 130 suggest superior ability (in the top 2 percent nationally). A score around 85 suggests below-average ability. A score in the range of 70 or below suggests significant impairment.
次要结局
- Change in Severity of Psychotic Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS)(baseline, 8 weeks)