NCT02970305已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 403
- 主要终点
- Change From Baseline to Week 26 in the Negative Symptom Assessment-16 (NSA-16) Total Score
研究概览
简要总结
To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of the negative symptoms of schizophrenia
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, between 18 and 55 years of age
- •A clinical diagnosis of schizophrenia with a minimum duration of 1 year
- •Has predominant negative symptoms according to predefined study criteria
- •The main background antipsychotic with which the subject is being treated must be one of the antipsychotics listed below:
- •Aripiprazole
- •Aripiprazole long-acting injectables:
- •Abilify Maintena®
- •Aristada®
- •Risperidone
- •Risperidone long-acting injection
- •Olanzapine
- •Lurasidone
- •Cariprazine
- •Brexpiprazole
- •Asenapine
排除标准
- •Patient has a psychiatric disorder other than schizophrenia
- •A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, except marijuana
- •a. Patients with a result indicating the presence of marijuana are permitted if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation
- •Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
- •Patient has had a myocardial infarction in the last six months
- •Patient has a family or personal history or symptoms of long QT syndrome
- •Patient has been hospitalized due to inadequate family support or care at the patient's primary residence, during the 8 weeks prior to screening
- •Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
研究组 & 干预措施
Pimavanserin
Experimental
Drug- pimavanserin 34 mg, 20 mg, or 10 mg taken as two tablets + background antipsychotic, once daily by mouth
干预措施: Pimavanserin (Drug)
Placebo
Placebo Comparator
Placebo, taken as two tablets + background antipsychotic, once daily by mouth
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 26 in the Negative Symptom Assessment-16 (NSA-16) Total Score
时间窗: From baseline to Week 26
The NSA-16 is a semi-structured interview and a validated scale containing 16 items for evaluating negative symptoms of schizophrenia, i.e. the reduction or absence of emotional expression and volitional behaviors normally present in a healthy person. Items are scored based on behaviors during the interview (items 1-4, 6, 7, 9, 11, 15, 16) or previous 7 days (items 5, 8, 10, 12-14) on a 6-point scale from 1 to 6. The NSA-16 total score is the sum of item scores. It can range from 16 to a maximum of 96, with higher scores denoting more severe negative symptoms in schizophrenia.
次要结局
- Proportion of Negative Symptom Assessment-16 (NSA-16) Responders at Week 26(From baseline to Week 26)
- Change From Baseline to Week 26 in NSA-16 Global Negative Symptoms Rating(From baseline to Week 26)
- Clinical Global Impression of Schizophrenia Scale-Improvement (CGI-SCH-I) of Negative Symptoms Score at Week 26(From baseline to Week 26)
- Change From Baseline to Week 26 in the Clinical Global Impression of Schizophrenia Scale-Severity (CGI-SCH-S) of Negative Symptoms Score(From baseline to Week 26)
- Proportion of CGI-SCH-I Responders (CGI-SCH-I Score of 1 or 2) at Week 26; Observed Cases(From baseline to Week 26)
- Change From Baseline to Week 26 in the Positive and Negative Syndrome Scale (PANSS) Total Score(From baseline to Week 26)
- Change From Baseline to Week 26 in Karolinska Sleepiness Scale (KSS) Score(From baseline to Week 26)
- Change From Baseline to Week 26 in the Personal and Social Performance Scale (PSP) Score(From baseline to Week 26)
- Change From Baseline (CFB) to Week 26 in NSA-16 Domain Scores(From baseline (BL) to Week 26)
- Change From Baseline to Week 26 in Brief Assessment of Cognition in Schizophrenia (BACS) Composite Score(From baseline to Week 26)
- Change From Baseline (CFB) to Week 26 in PANSS Subscale Scores(From baseline (BL) to Week 26)
- Change From Baseline to Week 26 in 10-item Drug Attitude Inventory (DAI-10) Score(From baseline to Week 26)
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