临床试验/NCT00715039

NCT00715039已完成不适用

A 4-Week, Double-Blind, Randomized, Multicenter, Fixed Dose, Placebo-Controlled, Parallel Group Study of Lorazepam and Paroxetine in Patients With Generalized Anxiety Disorder: Assessment of a New Instrument Intended to Capture Rapid Onset

Pfizer1 个研究点分布在 1 个国家目标入组 169 人开始时间: 2003年10月最近更新: 2008年10月3日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Pfizer
入组人数: 169
试验地点: 1
主要终点: Average change from baseline over the first 6 days of treatment assessment (Study Days 2 through 7) on the Daily Assessment of Symptoms - Anxiety (DAS-A) questionnaire.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study is to assess the performance characteristics of a new measure to assess onset of efficacy in a GAD patient population.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: Triple (Participant, Care Provider, Investigator)

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

•Primary Diagnosis of GAD (DSM IV, 300.02) as established by the clinician using all sources of data including the MINI structured interview
•HAM A score ³20 at the Screening (Study Day -7) and Baseline (Study Day 1) Visits by observer rating
•Good health as determined by medical history, physical examination, vital signs, electrocardiography (ECG), and clinical laboratory measurements
•Covi Anxiety Scale total score ³9 and Raskin Depression Scale total score £7 at the Screening Visit (to ensure predominance of anxiety symptoms over depression symptoms)
•Age 18 to 65 (inclusive)

排除标准

•Patients with most other current DSM-IV Axis I disorders.
•Patients with current or past schizophrenia, Psychotic disorder
•Delirium, dementia, amnestic, and other clinically significant cognitive disorders
•Bipolar or schizoaffective disorder
•Benzodiazepine abuse or dependence; and/or Factitious disorder.

研究组 & 干预措施

lorazepam

Active Comparator

干预措施: lorazepam (Drug)

placebo

Placebo Comparator

干预措施: placebo (Drug)

paroxetine

Active Comparator

干预措施: paroxetine (Drug)

结局指标

主要结局

Average change from baseline over the first 6 days of treatment assessment (Study Days 2 through 7) on the Daily Assessment of Symptoms - Anxiety (DAS-A) questionnaire.

时间窗: baseline, days 2 through 7

次要结局

CGIC at endpoint (LOCF)(endpoint)
PGIC at endpoint (LOCF)(endpoint)
SF-36v2 Mental Health change from baseline to endpoint (LOCF)(baseline, endpoint)
Change from baseline to daily time point (Study Days 2 through 7) on the DAS-A.(baseline and days 2 through 7)
DAS-A change from baseline to endpoint (LOCF)(baseline to endpoint)
Q-LES-Q change from baseline to endpoint (LOCF)(baseline, endpoint)
HADS-A change from baseline to endpoint (LOCF)(baseline, endpoint)
HADS-D change from baseline to endpoint (LOCF)(baseline, endpoint)
Change from baseline to endpoint (Weeks 1, 2, 4, and 5) in the HAM-A total score.(baseline and weeks 1,2,4, and 5)
DAS-A 30% and 50% improvement at endpoint;(endpoint)
DAS-A 30% sustained improvement beginning at week 1(baseline, week1, 2,4,)
HAM-A 30% sustained improvement beginning at week 1(baseline, weeks 1,2,4)
HAM-A 30% and 50% improvement at endpoint(endpoint)
GA-VAS average change from baseline over the first 6 days(baseline, days 2-7)
Change from baseline to daily time point on the GA-VAS(study days 2 through 7)(baseline, days 2-7)
GA-VAS change from baseline to endpoint(aseline, endpoint)
GA-VAS sustained 30% improvement beginning at week 1(baseline, weeks 1,2,4)
GA-VAS 30% and 50% improvement at endpoint(endpoint)

研究者

发起方

Pfizer

申办方类型

Industry

研究点 (1)

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