D-Serine Treatment of Negative Symptoms and Cognitive Deficits in Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Positive and Negative Syndrome Scale (PANSS)
研究概览
简要总结
This study is based on the hypothesis that by increasing N-methyl-D-aspartic acid (NMDA) receptor function in the brain and thereby increasing the capacity of the brain to both form new connections and strengthen existing connections, schizophrenic patients may derive both greater and sustained benefit from cognitive retraining.
详细描述
Patients with schizophrenia or schizoaffective disorder who are currently receiving antipsychotic medication will be randomly assigned in a double-blind manner to receive either D-serine (30 mg/kg) or placebo in addition to cognitive rehabilitation or a non-interactive placebo for 12 weeks.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Diagnosis of schizophrenia or schizoaffective disorder
- •Pregnant or lactating
排除标准
- 未提供
研究组 & 干预措施
Drug and control CRT
D-serine/control
干预措施: D-serine (Drug)
Drug and control CRT
D-serine/control
干预措施: Cognitive Retraining Placebo (Behavioral)
Drug and CRT
D-serine/cog rehab
干预措施: D-serine (Drug)
Drug and CRT
D-serine/cog rehab
干预措施: Cognitive Retraining (CRT) (Behavioral)
Placebo Drug and Placebo CRT
Placebo/control
干预措施: Placebo (Drug)
Placebo Drug and Placebo CRT
Placebo/control
干预措施: Cognitive Retraining Placebo (Behavioral)
Placebo Drug and CRT
Placebo/cog rehab
干预措施: Cognitive Retraining (CRT) (Behavioral)
Placebo Drug and CRT
Placebo/cog rehab
干预措施: Placebo (Drug)
结局指标
主要结局
Positive and Negative Syndrome Scale (PANSS)
时间窗: 12 weeks
The PANSS is a handscored instrument. It uses 25 PANSS items organized into five scales: Negative, Positive, Dysphoric Mood, Activation, and Autistic Preoccupation. The PANSS is based on findings that schizophrenia comprises at least two distinct syndromes. The positive syndrome consists of productive symptoms, while the negative syndrome consists of deficit features. This distinction is useful when developing treatment plans because you can focus on the type of symptoms the patient is experiencing. It is also useful when studying the effects of medication (e.g., in clinical drug trials) because it allows you to determine which type of symptoms are being affected. PANSS Total score minimum = 30, maximum = 210. The greater the score, the greater the symptoms.
Wisconsin Card Sorting Test (WCST)
时间窗: 12 weeks
The WCST allows the clinician to speculate to the following "frontal" lobe functions: strategic planning, organized searching, utilizing environmental feedback to shift cognitive sets, directing behavior toward achieving a goal, and modulating impulsive responding. The test can be administered to those from 6.5 years to 89 years of age.The test takes approximately 12-20 minutes to carry out and generates a number of psychometric scores, including numbers, percentages, and percentiles of: categories achieved, trials, errors, and perseverative errors. Can be interpreted as: the greater the percentage, the greater the measured ability.
Hopkins Verbal Learning Test
时间窗: 12 weeks
The Hopkins Verbal Learning Test is designed to assess verbal learning and memory (immediate recall, delayed recall, delayed recognition). The assessment takes approximately 5-10 minutes with a 25-minute delay to complete and 2 minutes to score. The greater the score, the greater the measured recall. The score ranges from 0 to 24.
Spatial Span- Total Score
时间窗: 12 weeks
The Spatial Span subtest of the Wechsler Memory Scale can be used as an indicator of working memory and visuospatial processing. An increase in severity of impairment results in a decrease in Spatial Span Total Score. The range is 1 to 28.
次要结局
- Heinrichs-Carpenter Quality of Life Scale(12 weeks)
- UCSD Performance-Based Skills Assessment (UPSA)(12 weeks)
- Simpson-Angus Neurological Rating Scale(12 weeks)
研究者
Deepak C. D'Souza
Associate Professor
Yale University