A 12 Week, Phase 2, Randomized, Double-blind, Placebo Controlled, Parallel Group Study To Evaluate The Safety And Efficacy Of Pf-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 35
- 试验地点
- 15
- 主要终点
- Change From Baseline in the MCCB (MATRICS Consensus Cognitive Battery) Working Memory Domain to Week 12
研究概览
简要总结
The purpose of this study is to determine whether PF-04958242 is safe and effective in the treatment of cognitive dysfunction in schizophrenia subjects
详细描述
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Otherwise healthy male and/or female subjects between the ages of 18 and 50 years, inclusive, with Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia of at least 2 years duration as confirmed by the M.I.N.I 7.0 for Psychotic Disorders
- •Evidence of stable schizophrenia symptomatology >=3 months (ie, no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia).
- •Subjects must be in ongoing maintenance atypical antipsychotic therapy (except clozapine), on a stable treatment regimen for >=2 months prior to Baseline/Day 1, including concomitant psychotropic treatments. Subjects should be on no more than 2 background antipsychotics.
- •Subject must have an identified informant
- •Subject must reside in a stable living situation for at least 12 weeks prior to Screening.
排除标准
- •Subjects with a current DSM-5 diagnosis of schizoaffective disorder in the judgment of the investigator.
- •Subjects with a current DSM-5 diagnosis of major depressive episode, manic and hypomanic episode, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder on the M.I.N.I 7.0 for Psychotic Disorders or in the judgment of the investigator.
- •Subjects with a lifetime DSM-5 diagnosis of antisocial personality disorder, anorexia nervosa, bulimia nervosa, binge-eating disorder on the M.I.N.I 7.0 for Psychotic Disorders or in the judgment of the investigator.
- •Subjects who meet the DSM-5 diagnosis of moderate or severe psychoactive substance use disorder (excluding nicotine dependence) within 12 months of screening on the M.I.N.I 7.0 for Psychotic Disorders interview and as determined by the investigator.
- •Subjects with significant extrapyramidal symptoms which have not been stabilized with anticholinergics.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Placebo
Participants received matching placebo oral capsule, twice daily (BID) for 12 weeks
干预措施: placebo (Drug)
0.15 mg PF-04958242
Participants received 0.15 mg oral capsule, twice daily (BID) for 12 weeks
干预措施: PF-04958242 (Drug)
0.5 mg PF-04958242
Participants received 0.5 mg oral capsule, twice daily (BID) for 12 weeks
干预措施: PF-04958242 (Drug)
结局指标
主要结局
Change From Baseline in the MCCB (MATRICS Consensus Cognitive Battery) Working Memory Domain to Week 12
时间窗: Baseline, Week 2, Week 6, Week 12
The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers' recommended scoring algorithms.
Change From Baseline in the UPSA-VIM (University of California, San Diego [UCSD] Performance Based Skills Assessment - Validation of Intermediate Measures) to Week 12
时间窗: Baseline, Week 6, Week 12
The UPSA-VIM is a functional capacity measure of 5 general skills that were previously identified as essential to functioning in the community: general organization, finance, social/communications, transportation, and household chores. The UCSD Performance Based Skills Assessment involves role play tasks that are administered as simulations of events that the person might encounter in the community.
次要结局
- Scale for the Assessment and Rating of Ataxia (SARA)(Baseline, Week 2, Week 6, Week 12)
- Number of Participants With Categorical Results on the Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline, followed by weekly (Weeks 1 throughout 12), and 28 days after last dose)
- Change From Baseline in the MCCB Neurocognitive Composite (Excluding Social Cognition Domain) to Week 12(Baseline, Week 2, Week 6, Week 12)
- Change From Baseline in MCCB Overall Composite (Including All 7 Domains) to Week 12(Baseline, Week 2, Week 6, Week 12)
- Change From Baseline in Each of the 6 Individual MCCB Domain Scores (Excluding MCCB Working Memory) to Week 12(Baseline, Week 2, Week 6, Week 12)
- Change From Baseline in the SCI-PANSS (Structured Clinical Interview Positive and Negative Symptoms Scale) Total to Week 12(Baseline, Week 2, Week 6, Week 12)
- Change From Baseline in the SCI-PANSS Positive, Negative and General Psychopathology Subscales to Week 12(Baseline, Week 2, Week 6, Week 12)
- Change From Baseline in the CGI-S (Clinical Global Impression-Severity) to Week 12(Baseline, Week 2, Week 6, Week 12)
- CGI-I (Clinical Global Impression-Improvement) at Week 12(Week 12)
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(For AEs, the time frame was from taking first dose through and including last visit (28 days after the last dose), up to 113 days. For SAEs, the time frame was from the time that the participant provided informed consent to last visit, up to 143 days.)
- Number of Participants With Laboratory Test Abnormalities(Screening up to Week 12 or early termination)
- Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings(Screening up to Week 12 or early termination)
- Number of Participants With Potentially Clinically Significant Vital Signs Findings(Screening up to Week 12 or early termination)
- Number of Participants With Abnormalities in Neurological Examination(Screening up to Week 12 or early termination)
- Number of Participants With Abnormalities in Physical Examination(Screening up to Week 12 or early termination)