Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Residual Schizophrenia
2期
已完成
NCT02477670
| 适应症 | Schizophrenia |
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| 分期 | 2期 |
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| 申办方 | Otsuka Pharmaceutical Development & Commercialization, Inc. |
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| 状态 | 已完成 |
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| 受试者人数 | 145 人 |
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| 干预（药物） | AVP-786 |
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| 开始日期 | 2015年9月1日 |
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| 完成日期 | 2017年7月21日 |
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| 结果公布日 | 2020年9月16日 |
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摘要
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.
Change From Baseline in the 16-Item Negative Symptom Assessment (NSA-16) Total Score at Week 6 and Week 12
Baseline and Week 6 (Stage 1); Baseline (Week 6) and Week 12 (Stage 2) · score on a scale
| Stage 1: AVP-786 | 61.0 ± 7.53 score on a scale |
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| Stage 1: Placebo | 60.4 ± 7.71 score on a scale |
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| Stage 1: AVP-786 | -5.0 ± 5.64 score on a scale |
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| Stage 1: Placebo | -3.4 ± 5.54 score on a scale |
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| Stage 1 Placebo Non-responders; Stage 2: Placebo | 57.6 ± 9.39 score on a scale |
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| Stage 1 Placebo Non-responders; Stage 2: AVP-786 | 57.6 ± 9.09 score on a scale |
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| p-value | 0.073 |
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| SPCD Weighted OLS z-statistic | -1.79 (95% CI -3.75–0.17) |
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。