NCT03896945终止2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Negative Symptoms of Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.60 个研究点 分布在 2 个国家目标入组 136 人开始时间: 2019年2月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 136
- 试验地点
- 60
- 主要终点
- Change from Baseline to Week 15 in the Positive and Negative Syndrome Scale (PANSS) Marder Negative Factors Score
研究概览
简要总结
This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786, as compared with placebo, for the treatment of 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) diagnostic criteria for schizophrenia confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) Version 7.0.2
- •Participants must have well-controlled positive symptoms and prominent negative symptoms as defined by Positive and Negative Syndrome Scale (PANSS) criteria.
- •Participants currently receiving a second-generation atypical antipsychotic drug (SGA) are eligible if they are stable and adherent to their dosing schedule.
- •Participants must have a reliable informant (e.g., case manager, social worker, family member). The informant should be able to spend an adequate amount of time with the participant to be able to address behaviors, activities, and symptoms.
排除标准
- •Participants with current major depressive disorder (MDD)
- •Participants with pseudo-parkinsonism secondary to their ongoing antipsychotic medication
- •Participants currently using anticholinergic medications
- •Participants recently hospitalized as in-patients
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo capsules will be administered orally twice a day over a 15-week period.
干预措施: Placebo (Drug)
AVP-786
Experimental
AVP-786 capsules will be administered orally twice a day over a 15-week period.
干预措施: AVP-786 (Drug)
结局指标
主要结局
Change from Baseline to Week 15 in the Positive and Negative Syndrome Scale (PANSS) Marder Negative Factors Score
时间窗: Baseline; Week 15
次要结局
- Change from Baseline to Week 15 in the Negative Symptom Assessment-16 (NSA-16) Global Negative Symptom Score(Baseline; Week 15)
- Change from Baseline to Week 15 in the Patient Global Impression of Severity (PGI-S) Score(Baseline; Week 15)
- Change from Baseline to Week 15 in the Patient Global Impression of Change (PGI-C) Score(Baseline; Week 15)
研究者
研究点 (60)
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