Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-flexible-dose Study of Lu AF11167 for the Treatment of Persistent Prominent Negative Symptoms in Patients With Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 168
- 试验地点
- 53
- 主要终点
- Change in Negative Symptom Scale (BNSS) total score
研究概览
简要总结
A study to evaluate the efficacy of 2 fixed-flexible doses of Lu AF11167 on negative symptoms in patients with 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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lu AF11167 low dose
干预措施: Lu AF11167 (1-2 mg/day) (Drug)
Lu AF11167 high dose
干预措施: Lu AF11167 (3-4 mg/day) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Negative Symptom Scale (BNSS) total score
时间窗: from baseline to Week 12
The BNSS is a brief clinician rating scale, intended to measure negative symptoms. It consists of 13 items organized into 6 subscales: anhedonia, distress, asociality, avolition, blunted affect and alogia. The items score the impairment. Items 1 to 4 are rated from 0 (Normal) to 6 (Extremely severe) and items 5 to 13 are rated from 0 (No impairment) to 6 (Severe deficit). The BNSS total score is calculated by summing the 13 individual items; subscale scores are calculated by summing the individual items within each subscale. Users of the BNSS should have training in psychiatric interview techniques and have clinical experience working with patients with schizophrenia and related psychotic disorders. The BNSS total scores ranges from 0 to 78.
次要结局
- Change in PANSS Negative subscale score(from baseline to Week 12)
- CGI-SCH-DC negative symptoms response(at Week 12)
- Clinical Global Impression - Schizophrenia (CGI-SCH-DC) degree of change in overall severity score(at Week 12)
- Change in Positive and Negative Syndrome Scale (PANSS) total score(from baseline to Week 12)
- Change in PANSS Marder Negative Symptom Factor score: negative symptoms(from baseline to Week 12)
- Clinical Global Impression - Schizophrenia (CGI-SCH-DC) negative symptoms score(at Week 12)
- Change in Personal and Social Performance (PSP) score(from baseline to Week 12)
- Change in Clinical Global Impression - Schizophrenia (CGI-SCH-S) negative symptoms score(from baseline to Week 12)
- Change in Clinical Global Impression - Schizophrenia (CGI-SCH-S) severity of illness overall severity score(from baseline to Week 12)
- BNSS response(at Week 12)
- Change in PANSS -Positive subscale score(from baseline to Week 12)
- Change in Calgary Depression Scale for Schizophrenia (CDSS) total score(from baseline to Week 12)