NCT02970292已完成3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 396
- 主要终点
- Change From Baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) 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 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
- •Adults patients, between 18 and 55 years of age
- •A clinical diagnosis of schizophrenia with a minimum duration of 1 year
- •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
- •Has had a partial but inadequate response to antipsychotic treatment
- •Has a history of response to antipsychotic treatment other than clozapine
排除标准
- •Patient has a psychiatric disorder other than schizophrenia
- •Patient has a history of resistance to antipsychotic treatment
- •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 is taking a medication or drug that prolongs the QT interval or has a family or personal history or symptoms of long QT syndrome
- •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 + background antipsychotic, taken as two tablets, once daily by mouth
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score
时间窗: From baseline to Week 6
The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items (P1 to P7), 7 negative symptom items (N1 to N7), and 16 general psychopathology symptom items (G1 to G16). Items are scored over the past week (7 days) on a 7-point scale ranging from 1 (absent) to 7 (extreme). The PANSS total score can range from a minimum of 30 to a maximum of 210, where a higher score signifies greater severity of schizophrenia symptoms.
次要结局
- Change From Baseline to Week 6 in the Clinical Global Impression-Severity (CGI-S) Score(From baseline to Week 6)
- Change From Baseline (CFBL) to Week 6 in PANSS Subscale Scores, i.e. PANSS Positive Subscale Score, PANSS Negative Subscale Score and PANSS General Psychopathological Scale Score(From baseline to Week 6)
- PANSS Responders(From baseline to Week 6)
- Clinical Global Impression-Improvement (CGI-I) Response(From baseline to Week 6)
- Clinical Global Impression-Improvement (CGI-I) Score at Week 6(From baseline to Week 6)
- Change From Baseline to Week 6 in Personal and Social Performance (PSP) Scale Score(From baseline to Week 6)
- Drug Attitude Inventory (DAI-10)(From baseline to Week 6)
- Change From Baseline to Week 6 in Karolinska Sleepiness Scale (KSS) Score(From baseline to Week 6)
研究者
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