NCT00658762终止3 期
A Phase 3, Randomized, Double-Blind, Parallel Group, 10-Week Placebo Controlled Fixed Dose Study of PD 0332334 and Paroxetine 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
- 终止
- 发起方
- Pfizer
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of PD 0332334 in subjects with GAD
研究概览
简要总结
This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects ages 18 and older with generalized anxiety disorder.
详细描述
Termination reason: On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.
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 225 mg BID
Experimental
干预措施: PD 0332334 (Drug)
PD 0332334 300 mg BID
Experimental
干预措施: PD 0332334 (Drug)
Paroxetine 20 mg q am
Active Comparator
干预措施: paroxetine (Drug)
Placebo BID
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the safety and tolerability of PD 0332334 in subjects with GAD
时间窗: 8 weeks with taper
Change from Baseline in HAM-A total score at Week 8
时间窗: 8 weeks
次要结局
- Response rate on the HAM-A at Week 1 and Week 8(8 weeks)
- Response rate on the PGI-C at Week 8(8 weeks)
- Remission rate based on the HAM-A at Week 8(8 weeks)
- Change from Baseline in the somatic subscale score of the HAM-A (item 7-13) at Week 8(8 weeks)
- Change from Baseline to Week 8 on the Medical Outcomes Study - Sleep Scale subscales(8 weeks)
- Worsening and improvement (from Baseline to Week 8) on the Changes in Sexual Functioning Questionnaire (CSFQ).(8 weeks)
- Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score(8 weeks)
- Change from Baseline in the HAM-A total score at Weeks 1, 2, 4 and 6)(6 weeks)
- Response rate on the CGI-I at Week 1 and Week 8(8 weeks)
- Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) Sleep Disturbance Score(8 weeks)
- Average (across the Week 1, 2, 4, 6 and 8 visits) HAM-A Change from Baseline score(8 weeks)
- Change from Baseline to Days 2-8 and Weeks 2, 4, 6 and 8 on the GA-VAS (diary)(8 weeks)
- The "Week 1 Sustained Responser" rate based on the HAM-A(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 Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (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) Sleep Disturbance Score(1 week)
- Change from Baseline in the 17-item HAM-D total score at Weeks 1, 2, 4, and 8(8 weeks)
- Change from Baseline in CGI-S at Week 8(8 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
终止
3 期
A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (2)Generalized Anxiety DisorderNCT00658372Pfizer360
终止
3 期
A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (1)Generalized Anxiety DisorderNCT00658008Pfizer501
撤回
3 期
A Study to Evaluate the Efficacy and Safety of REL-1017 As Adjunctive Treatment of Major Depressive Disorder (MDD)Major Depressive Disorder (MDD)NCT06735079MGGM LLC146
撤回
3 期
CBP-201 in Adolescent and Adult Patients With Moderate-to-severe Atopic DermatitisAtopic DermatitisNCT05614817Suzhou Connect Biopharmaceuticals, Ltd.
进行中（未招募）
3 期
A Phase 3 Study of VSA001 in Chinese Adults With Familial Chylomicronemia SyndromeFamilial Chylomicronemia SyndromeNCT05902598Visirna Therapeutics HK Limited37