NCT00921063已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 5-Week Trial To Assess The Efficacy And Safety Of PD 0332334 Compared To Placebo And Alprazolam Extended-Release In Patients With Generalized Anxiety Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 222
- 主要终点
- HAM-A Total Score
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of PD 0332334 compared to placebo in the treatment of Generalized Anxiety Disorder in an adult population
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
- Double (Participant, 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
- •Healthy males or females with a diagnosis of Generalized Anxiety Disorder (GAD) (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02).
- •HAM-A Total Score ≥20 and item #1 on the HAM-D (depressed mood score) ≤2 at both Screening and Baseline/Randomization.
排除标准
- •Current diagnoses (within the 6 months) of Major Depressive Disorder; Obsessive Compulsive Disorder; Panic Disorder; Posttraumatic Stress Disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder;
- •Any of the following past or current diagnoses: Schizophrenia; Psychotic Disorder; Delirium, Dementia, Bipolar or Schizoaffective Disorder; Cyclothymic Disorder; Dissociative Disorders; Antisocial or borderline personality disorder
- •Current use of psychotropic medications (i.e., drugs normally prescribed for depression, mania, anxiety, insomnia, or psychosis) that could not be discontinued 2 weeks prior to dosing.
研究组 & 干预措施
PD 0332334 100 mg
Experimental
干预措施: PD 0332334 (Drug)
PD 0332334 250 mg
Experimental
干预措施: PD 0332334 (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
Alprazolam extended release
Active Comparator
干预措施: Alprazolam extended release (Drug)
结局指标
主要结局
HAM-A Total Score
时间窗: 4 weeks
次要结局
- HAM-A total score at week 1, 2 and 4(1. 2. ands 4 weeks)
- HAM-A somatic and psychic subscales(1, 2, and 4 weeks)
- HAM-A responders(4 weeks)
- HAM-A sustained responders(Week 1 through week 4)
- DAS-A (daily assessment of symptoms of anxiety) and GA-VAS (VAS scale for global anxiety)(Day 2 through day 7)
- CGI-I (Clinical Global Impression of Improvement) and PGI-I (Patient Global Impression of Change)(1 and 4 weeks)
- HAM-D total score(1 and 4 weeks)
- Sheehan Disability Score (SDS)(4 weeks)
- Treatment Satisfaction Questionaire for Medication(4 weeks)
研究者
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