NCT00542685已完成3 期
A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Group, 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 551
- 试验地点
- 1
- 主要终点
- The efficacy of PD 0332334 in the treatment of GAD will be measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline observed following 8 weeks of double-blind treatment.
研究概览
简要总结
This study will evaluate the efficacy and safety of PD 0332334 for the treatment of generalized anxiety disorder.
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 GAD (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the Mini International Neuropsychiatric Interview (MINI) for DSM-IV Axis I disorders and other clinical information. Subjects with specific phobia(s) (as defined in DSM-IV) or dysthymic disorder will be allowed in the study.
- •Subjects must have a HAM-A total score ≥20 at the screening (V1) and randomization (V2) visits. Subjects must also have a Covi Anxiety Scale score of >9 and a Raskin Depression Scale score <7 at the Screening (V1) visit to ensure predominance of anxiety symptoms over depression symptoms.
排除标准
- •Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies).
- •Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnoses: Major depressive disorder, Obsessive compulsive disorder, Panic disorder; Agoraphobia, Posttraumatic stress disorder, Anorexia, Bulimia, Caffeine-induced anxiety disorder, Alcohol or substance abuse or dependence unless in full remission for at least 6 months, Social anxiety disorder.
- •Any of the following past or current DSM IV Axis I diagnoses: Schizophrenia, Psychotic disorder, Delirium, dementia, amnestic, and other clinically significant cognitive disorders, Bipolar or schizoaffective disorder, Cyclothymic disorder, Dissociative disorders.
- •Antisocial or borderline personality disorder.
- •Serious suicidal risk per the clinical investigator's judgment.
研究组 & 干预措施
PD 0332334 300 mg BID
Experimental
干预措施: PD 0332334 (Drug)
Placebo BID
Placebo Comparator
干预措施: Placebo (Drug)
PD 0332334 225 mg BID
Experimental
干预措施: PD 0332334 (Drug)
PD 0332334 175 mg BID
Experimental
干预措施: PD 0332334 (Drug)
结局指标
主要结局
The efficacy of PD 0332334 in the treatment of GAD will be measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline observed following 8 weeks of double-blind treatment.
时间窗: 8 weeks
The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study.
时间窗: 8 weeks
次要结局
- Response rate on the clinician-rated CGI-I at Week 1 and Week 8.(8 weeks)
- Change from Baseline to Week 8 on the Medical Outcomes Study-Sleep Scale (MOSS-SS) subscales.(8 weeks)
- Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score.(8 weeks)
- Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score).(8 weeks)
- Response rate on the HAM-A at Week 1 and Week 8.(8 weeks)
- Change from Baseline in the somatic subscale score of the HAM-A (Items 7-13) at Week 8.(8 weeks)
- Remission rate based on the HAM-A at Week 1 and Week 8.(8 weeks)
- Response rate on the patient-rated PGI-C at Week 8.(8 weeks)
- The "Week 1 Sustained Responder" rate based on the HAM-A (where "Week 1 Sustained Responders" are defined as subjects with a 50% or greater improvement from baseline on the HAM-A total score at Week 1 that is sustained until the Week 8 visit).(1 week)
- Change from Baseline in HAM-A total score at Weeks 1, 2, 4, and 6.(6 weeks)
- Change from Baseline in the 17-item HAM-D total score at Weeks 1, 2, 4, and 8.(8 weeks)
- Change from Baseline to Week 8 on the Sheehan Disability Scale subscales.(8 weeks)
- Change from Baseline in CGI-S at Week 8.(8 weeks)
- Change from Baseline in the psychic subscale score of the HAM-A (Items 1-6 and 14) at Week 8.(8 weeks)
- Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score.(8 weeks)
- Change from Baseline to Week 8 in the Q-Les-Q General Activities Score.(8 weeks)
- Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score.(1 week)
- Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the GA-VAS (diary).(8 weeks)
研究者
研究点 (1)
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