Evaluation of Negative Symptoms and Cognitive Function After Administration of Antipsychotics in Healthy Volunteer: a Double-blind, Randomized Trial of a Single Dose of Placebo, Haloperidol, Amisulpride, Risperidone and Aripiprazole
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Symptoms assessment by objective and subjective rating scales & CNT
研究概览
简要总结
The aim of the study is to investigate the negative symptoms and cognitive function after administration of antipsychotics in healthy volunteer.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-38 years and meet no DSM-IV diagnostic criteria as assessed by using the Structured Clinical Interview for DSM-IV, research version.
排除标准
- •anyone who participated in other clinical trials within 30 days from the start of this clinical trial or is currently participating in one,
- •anyone who has progressive disease or in unstable medical condition unfit for the trial,
- •anyone who has been diagnosed in psychiatric terms in the past, depends on psychotropic substance, or has overdosed or depended on the substance or alcohol (except for coffee or tobacco) within 1 month from the trial start,
- •anyone who is suicidal or highly probable of suicides, or
- •anyone who has test results considered clinically meaningful
研究组 & 干预措施
aripiprazole
干预措施: aripiprazole (Drug)
risperidone
干预措施: risperidone (Drug)
haloperidol
干预措施: haloperidol (Drug)
amisulpride
干预措施: amisulpride (Drug)
lactose
干预措施: lactose (Drug)
结局指标
主要结局
Symptoms assessment by objective and subjective rating scales & CNT
时间窗: 4hour
SANS-alogia and blunted affect, SDSS-Subjective Deficit Syndrome Scale ,self-report questionnaire to measure lack of energy, blunted affect, and difficulty in or altered thinking, consisting of 19 questions, with the scales from 0 to 4 NIDSS-consists of 20 items with a five-point Likert scale (from 0, none to 4, severe) and has three subscales: avolition (five items), blunted affect (five items), and cognition (ten items), CNT-computerized neuropsychological test, VAS
Symptoms assessment by objective and subjective rating scale
时间窗: 2 hour
VAS - mental sedation (alert-drowsy, muzzy-clear headed, mentally slow-quick witted, attentive-dreamy), physical sedation (strong-feeble, well coordinated-clumsy, lethargic-energetic, incompetent-proficient), tranquilization (calm-excited, contented-discontented, troubled-tranquil, tense-relaxed)
Symptoms assessment by objective and subjective rating scales
时间窗: 24hour
SANS, SDSS, NIDSS, VAS SANS-alogia and blunted affect, SDSS-Subjective Deficit Syndrome Scale ,self-report questionnaire to measure lack of energy, blunted affect, and difficulty in or altered thinking, consisting of 19 questions, with the scales from 0 to 4 NIDSS-consists of 20 items with a five-point Likert scale (from 0, none to 4, severe) and has three subscales: avolition (five items), blunted affect (five items), and cognition (ten items), VAS
次要结局
- Symptoms assessment by objective rating scale(24hour)