NCT00658372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
- 360
- 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 is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects, ages 18 to 65, with generalized anxiety disorder.
详细描述
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
- Quadruple (Participant, Care Provider, 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 diagnosis: 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 QD
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
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
- Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score(8 weeks)
- Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6(6 weeks)
- Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales(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 to Days 2- 8 and Weeks 2, 4, 6, 8 on the DAS A (total score)(8 weeks)
- Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score(8 weeks)
- Response rate on the HAM-A at week 1 and week 8(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 the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8(8 weeks)
- Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13)(8 weeks)
- Change from baseline to week 8 in the QLesQ General Activity Score(8 weeks)
- Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ)(8 weeks)
- Remission rate based on the HAM A at Week 8(8 weeks)
- Response rate on the clinician-rated CGI-I ate week 1 and week 8(8 weeks)
- Change from baseline in CGI-S at week 8(8 weeks)
- Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary)(8 weeks)
- Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score(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 for the Treatment of Generalized Anxiety Disorder (3)Generalized Anxiety DisorderNCT00658762Pfizer286
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