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) (J2S-MC-GZMK)

未提供0 个研究点目标入组 450 人开始时间: 待定

适应症

试验速览

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•Meet the diagnostic criteria of schizophrenia
•Are on a stable standard of care medication regimen for schizophrenia
•If the duration of illness is >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

•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

发起方

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