CTRI/2026/04/109019尚未招募2 期
A Phase 2 Multicenter, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Adult Participants With Schizophrenia (RENEW-Scz-1)
Eli Lilly and Company (India) Pvt Ltd11 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2026年5月16日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 450
- 试验地点
- 11
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC for treatment of schizophrenia.
The trial is divided into three periods as follows: Screening period will last approximately 1 month, treatment period will last a maximum of 12 months, and the follow up period will last approximately 2 months. The length of time of your study participation may last up to approximately 15 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Meet the diagnostic criteria of schizophrenia
- •Are on a stable standard of care medication regimen for schizophrenia
- •If the duration of illness is more than 6 years, participant has experienced at least one relapse of schizophrenia in last 3 years
- •Have at least 1 reliable study partner (for example, a family member, social worker, caseworker, residential facility staff, or nurse)
- •Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as.
- •self-inject study intervention store and use the provided study intervention as directed,.
- •maintain electronic or paper study diaries, as applicable, and.
- •complete the required questionnaires.
排除标准
- •Have lifetime history of bipolar disorder, borderline personality disorder, or any eating disorder
- •Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
- •Have type 1 diabetes, or history of ketoacidosis or hyperosmolar state or coma
- •Are actively suicidal or deemed to be a significant risk for suicide
- •Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
研究者
Dr Rahul Kapur
Eli Lilly and Company (India) Pvt. Ltd
研究点 (11)
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