跳至主要内容
临床试验/NCT01185418
NCT01185418已完成不适用

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

Chonbuk National University Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物

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

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)

研究者

申办方类型
Other

研究点 (1)

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