NCT05838625已完成3 期
A Randomized, Multicenter, 16-week Study to Evaluate the Efficacy and Safety of Two Prescription Digital Therapeutics as an Adjunct to Standard-of-Care Antipsychotic Therapy in Adult and Late Adolescent Participants With Experiential Negative Symptoms of Schizophrenia
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 464
- 试验地点
- 56
- 主要终点
- Experiential negative symptoms
研究概览
简要总结
This study evaluates the efficacy of two prescription digital therapeutics (PDT) in addition to standard of care (SOC) therapy for the treatment of experiential negative symptoms of schizophrenia in late adolescents and adults.
详细描述
The purpose of the proposed study is to evaluate the efficacy and safety of two prescription digital therapeutics as an adjunct treatment to SOC in participants 18 years of age or older diagnosed with experiential 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A participant will be eligible for entry into the study if all of the following criteria are met:
- •Has a primary diagnosis of schizophrenia.
- •Is on a stable dose of antipsychotic medication(s).
- •Has obtained an average score of ≥2 (moderate to severe) in at least two of the three CAINS-MAP domains (Social, Work, or Recreational).
排除标准
- •A participant will not be eligible for study entry if any of the following criteria are met:
- •Is currently treated with more than two antipsychotic medications (including more than two dosage forms).
- •Meets DSM-5, for diagnoses not under investigation.
- •Has participated in a CT-155 clinical study.
结局指标
主要结局
Experiential negative symptoms
时间窗: Baseline to Week 16
Change from baseline to Week 16 in experiential negative symptoms, as assessed by Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP)
次要结局
- Expressive negative symptoms(Baseline to Weeks 8 and 16)
- Self-reported defeatist beliefs(Baseline to Weeks 8 and 16)
- Motivation and pleasure symptoms(Baseline to Week 8)
- Social functioning(Baseline to Weeks 8 and 16)
- Patient global impression of improvement(Weeks 8 and 16)
- Positive symptoms(Baseline to Weeks 8 and 16)
研究者
研究点 (56)
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