A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат Brenipatide
  Administered SC
• Препарат Placebo
  Administered SC

Первичные конечные точки

• Time to Relapse Defined as Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion [Срок оценки: Randomization up to at least 6 months]

Вторичные конечные точки (9)

• Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score [Срок оценки: Baseline, up to at least 6 months]
• Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score [Срок оценки: Baseline, up to at least 6 months]
• Change from Baseline in Young Mania Rating Scale (YMRS) Total Score [Срок оценки: Baseline, up to at least 6 months]
• Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score [Срок оценки: Baseline, up to at least 6 months]
• Change from Baseline in Patient Rated Outcome as Measured by Patient's Global Impression of Severity (PGI-S) [Срок оценки: Baseline, up to at least 6 months]
• Mean Percent Change in Body Weight in Participants with a Baseline Body Mass Index (BMI) of ≥25 kg/m2 [Срок оценки: Baseline, up to at least 6 months]
• Mean Percent Change in Body Weight in Participants with a Baseline Body Mass Index (BMI) of ≥25 kg/m2 and on an Atypical Antipsychotic [Срок оценки: Baseline, up to at least 6 months]
• Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide [Срок оценки: Baseline, up to at least 6 months]
• Number of Participants with Treatment-Emergent Anti-Drug Antibodies [Срок оценки: Baseline, up to at least 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 20 центров

• ATP Clinical Research — Orange
• Yale University School of Medicine — New Haven
• AGA Clinical Trials — Hialeah
• Accel Research Sites - Maitland Clinical Research Unit — Maitland
• K2 Medical Research - Maitland — Maitland
• Floridian Clinical Research, LLC — Miami Lakes
• CLA Research — Naples
• Charter Research - Orlando — Orlando
• … и ещё 12 центров

Япония · 15 центров

• Uematsu Mental Clinic — Chikugo
• Jimbocho Mental Clinic — Chiyoda City
• Horikoshi Mental Somatic Clinic — Fukushima
• Saitama Medical University Hospital — Iruma
• Rainbow and Sea Hospital — Karatsu
• Monzen-nakacho Mental Clinic — Kōtō City
• Suizenji Life Clinic — Kumamoto
• Kure Medical Center — Kure
• … и ещё 7 центров

Индия · 13 центров

• Galaxy Superspeciality Hospital — Aurangabad
• Belagavi Institute of Medical Sciences - Belagavi — Belgavi
• All India Institute of Medical Sciences (AIIMS) - Bhopal — Bhopal
• Society for Psychiatric Update and Research — Chhatrapati Sambhajinagar
• Graphic Era Institute of Medical Sciences and Hospital — Dehradun
• Dharwad Institute Of Mental Health And Neurosciences — Dharwad
• Dr. Ram Manohar Lohia Institute of Medical Sciences — Lucknow
• Career Institute of Medical Sciences and Hospital - Lucknow — Lucknow
• … и ещё 5 центров

Аргентина · 12 центров

• Hospital Italiano de Buenos Aires — ABB
• Centro Neurobiológico y de Estrés Traumático (CENydET) — Buenos Aires
• Instituto Nacional de Psicopatología (INAPsi)- FunDaMos — Buenos Aires
• Stat Research S.A. — Buenos Aires
• Mautalen Salud e Investigación — Buenos Aires
• Instituto Médico DAMIC — Córdoba
• Instituto Kremer — Córdoba
• Centro Médico Luquez — Córdoba
• … и ещё 4 центра

Китай · 10 центров

• The Second People's Hospital of Hunan Province — Чанша
• The Seventh People's Hospital of Hangzhou — Ханчжоу
• 3rd People's Hospital of Huzhou — Huzhou
• Shangdong Mental Health Center — Цзинань
• Shanghai Mental Health Center — Шанхай
• Shanghai Tongji Hospital — Шанхай
• The First Hospital of Hebei Medical University — Shijiazhuang
• Tianjin Anding Hospital — Тяньцзинь
• … и ещё 2 центра

Бразилия · 9 центров

• Chronos Pesquisa Clínica — Brasília
• Instituto de Pesquisa clinica de Campinas — Campinas
• Centro de Pesquisa Clínica de Marília - CPCLIM — Marília
• Ruschel Medicina e Pesquisa Clínica — Rio de Janeiro
• Facili Centro Integrado de Psiquiatria — São Bernardo do Campo
• CPQuali Pesquisa Clínica — São Paulo
• BR Trials - Ensaios Clinicos e Consultoria — São Paulo
• Clinica Viver - Centro de Desospitalizacao Humana — São Paulo
• … и ещё 1 центр

Мексика · 7 центров

• Scientia Investigacion Clinica S.C. — Chihuahua City
• … и ещё 6 центров

Пуэрто-Рико · 1 центр

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07286175 · 27365 · J2S-MC-GZMJ

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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