CTRI/2026/03/106554尚未招募2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
Eli Lilly and Company (India) Pvt Ltd10 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026年5月1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
- 400
- 试验地点
- 10
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 with placebo plus SoC in delaying the worsening of bipolar disorder symptoms.
The trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if bipolar symptoms worsen or if withdrawal from the study occurs for any reason.
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 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Meet the diagnostic criteria for bipolar disorder I or bipolar disorder II
- •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 blinded study intervention, as directed.
- •maintain electronic and paper study diaries, as applicable, and.
- •complete the required questionnaires
- •Are on stable standard of care medication for bipolar disorder.
排除标准
- •Have a lifetime history or current diagnosis of the following according to DSM-5 criteria:.
- •schizophrenia or other psychotic disorder.
- •borderline personality disorder, or.
- •any eating disorder
- •Have type 1 diabetes mellitus, or a history of.
- •ketoacidosis, or.
- •hyperosmolar state or coma
- •Have evidence of moderate or severe substance or alcohol use disorder within the past 180 days prior to screening
- •Are actively suicidal and or deemed to be at significant risk for suicide
- •Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening.
研究者
Dr Rahul Kapur
Eli Lilly and Company (India) Pvt. Ltd
研究点 (10)
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