NCT02477670已完成2 期
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Sequential Parallel Comparison Design (SPCD) Study to Assess the Efficacy, Safety and Tolerability of AVP-786 (Deuterated [d6]-Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) as an Adjunctive Treatment for Patients With Residual Schizophrenia
Avanir Pharmaceuticals17 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 17
- 主要终点
- Change From Baseline in the 16-Item Negative Symptom Assessment (NSA-16) Total Score at Week 6 and Week 12
研究概览
简要总结
The objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability of AVP-786 as an adjunctive treatment compared with placebo in patients with residual 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
- •Patients who meet DSM-IV-TR diagnostic criteria for schizophrenia using the M.I.N.I. version 6.
- •Patients must meet PANSS criteria
- •Patients currently receiving atypical antipsychotics are eligible provided they are on a stable dose
排除标准
- •Patients with current major depressive disorder (MDD)
- •Patients with extrapyramidal syndrome secondary to their ongoing antipsychotic medication
- •Patients currently using anticholinergic medications
- •Recent in-patient hospitalization
研究组 & 干预措施
AVP-786
Experimental
AVP-786 dose 2 capsules administered twice a day over a 12-week period
干预措施: AVP-786 (Drug)
Placebo
Placebo Comparator
Placebo capsules administered twice a day over a 12-week period
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the 16-Item Negative Symptom Assessment (NSA-16) Total Score at Week 6 and Week 12
时间窗: Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2)
The NSA-16 is a measure of the presence, severity, and range of negative symptoms associated with schizophrenia. It has a high interrater and test-retest reliability across languages and cultures. The NSA-16 uses a 5-factor model to describe negative symptoms: (1) communication, (2) emotion/affect, (3) social involvement, (4) motivation, and (5) retardation. The possible NSA-16 total score ranges from 16 to 96, with a higher score indicating a worse condition. Change was Baseline was calculated as the post-Baseline value minus the Baseline value.
次要结局
- Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the PANSS Negative Subscale Score at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the NSA-16 Communication Domain Score at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the PANSS Prosocial Factor Subscale Score at Week 6 at Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the PANSS General Psychopathology Subscale Score at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the NSA-16 Retardation Domain Score at Week 6 at Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite Score at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the PANSS Marder Negative Factor Score at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the PANSS Excitement Component Subscale Score at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the PANSS Positive Subscale Score at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the NSA-16 Global Negative Symptoms Score at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Mean Actual Clinical Global Impression of Change (CGI-C) Score at Week 6 and Week 12(Baseline, Week 6 (Stage 1), Week 12 (Stage 2))
- Change From Baseline in the Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the NSA-16 Emotion/Affect Domain Score at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the NSA-16 Social Involvement Domain Score at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the NSA-16 Motivation Domain Score at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the NSA-16 Global Level of Functioning Score at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Mean Actual Clinical Global Impression of Severity (CGI-S) of Illness Score at Week 6 and Week 12(Week 6 (Stage 1); Week 12 (Stage 2))
- Mean Actual Patient Global Impression of Change (PGI-C) Score at Week 6 at Week 12(Baseline, Week 6 (Stage 1), Week 12 (Stage 2))
- Change From Baseline in the EEfRT Score for Completed Tasks at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the Effort Expenditure for Reward Task (EEfRT) Score for Baseline Press Rate at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the EEfRT Score for Choice Reaction Time (RT) 1st 50 at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the EEfRT Score for 12% Probability-Proportion High Effort Opts at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the EEfRT Score for 50% Probability-Proportion High Effort Opts 1st 50 at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the EEfRT Score for All-Proportion High Effort Opts 1st 50 at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the EEfRT Score for 88% Probability-Proportion High Effort Opts 1st 50 at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the EEfRT Score for Difference - Proportion High Effort Opts 1st 50 at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Number of Participants With a Reduction of 20% or Greater in the PANSS Total Score at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
- Change From Baseline in the 4-Item NSA (NSA-4) Total Score at Week 6 and Week 12(Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2))
研究者
研究点 (17)
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