EUCTR2021-001352-33-BG进行中（未招募）1 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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 370
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients 18 to 60 years of age, inclusive, at time of informed consent.
- •2. 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
- •3. Participants must have well-controlled positive symptoms and
- •prominent negative symptoms as defined by Positive and Negative
- •Syndrome Scale (PANSS) criteria.
- •4. Participants should be treated with second-generation atypical
- •antipsychotic drug (SGA) including long-acting injectable (LAI)
- •treatments, are eligible if they are stable and adherent to their dosing
- •5. 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.
- •Please refer to the protocol for complete list of inclusion criteria.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 370
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Participants with current major depressive disorder (MDD)
- •2. Patients with a diagnosis of schizoaffective disorder or bipolar
- •3. Participants currently using anticholinergic medications
- •4. Participants recently hospitalized as in-patients
- •Please refer to protocol for complete list of exclusion criteria.
研究者
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