Bipolar Disorder (BPD) Clinical Trials

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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)

Status: Recruiting
Location: See all (87) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
California
ATP Clinical Research
RECRUITING
Orange
Connecticut
Yale University School of Medicine
RECRUITING
New Haven
Florida
AGA Clinical Trials
RECRUITING
Hialeah
Accel Research Sites - Maitland Clinical Research Unit
RECRUITING
Maitland
K2 Medical Research - Maitland
RECRUITING
Maitland
Floridian Clinical Research, LLC
RECRUITING
Miami Lakes
CLA Research
RECRUITING
Naples
Charter Research - Orlando
RECRUITING
Orlando
Encore Medical Research - Weston
RECRUITING
Weston
Georgia
Atlanta Center for Medical Research
RECRUITING
Atlanta
Iowa
Covenant Medical Center
RECRUITING
Waterloo
Massachusetts
Elixia MA
RECRUITING
Springfield
Adams Clinical Watertown
RECRUITING
Watertown
Maryland
CBH Health
RECRUITING
Gaithersburg
Pennsylvania
Penn Medicine: University of Pennsylvania Health System
RECRUITING
Philadelphia
Texas
Revival Research Institute, LLC
RECRUITING
Mckinney
Pillar Clinical Research - Richardson
RECRUITING
Richardson
Utah
Alpine Research Organization
RECRUITING
Clinton
Virginia
Re:Cognition Health
RECRUITING
Fairfax
Washington
Northwest Clinical Research Center
RECRUITING
Bellevue
Other Locations
Argentina
Hospital Italiano de Buenos Aires
NOT_YET_RECRUITING
Abb
Centro Neurobiológico y de Estrés Traumático (CENydET)
RECRUITING
Buenos Aires
Instituto Nacional de Psicopatología (INAPsi)- FunDaMos
RECRUITING
Buenos Aires
Mautalen Salud e Investigación
RECRUITING
Buenos Aires
Stat Research S.A.
NOT_YET_RECRUITING
Buenos Aires
Centro Médico Luquez
RECRUITING
Córdoba
Instituto Kremer
RECRUITING
Córdoba
Instituto Médico DAMIC
RECRUITING
Córdoba
Global Psy Asociación Civil
RECRUITING
La Plata
Fundacion Scherbovsky
RECRUITING
Mendoza
INECO Neurociencias Oroño
RECRUITING
Rosario
Clinica El Jardin
RECRUITING
Santiago Del Estero
Brazil
Chronos Pesquisa Clínica
RECRUITING
Brasília
Instituto de Pesquisa clinica de Campinas
RECRUITING
Campinas
Centro de Pesquisa Clínica de Marília - CPCLIM
RECRUITING
Marília
Ruschel Medicina e Pesquisa Clínica
NOT_YET_RECRUITING
Rio De Janeiro
Facili Centro Integrado de Psiquiatria
RECRUITING
São Bernardo Do Campo
BR Trials - Ensaios Clinicos e Consultoria
RECRUITING
São Paulo
Clinica Viver - Centro de Desospitalizacao Humana
RECRUITING
São Paulo
CPQuali Pesquisa Clínica
RECRUITING
São Paulo
A2Z Clinical Centro Avançado De Pesquisa Clínica - Valinhos
RECRUITING
Valinhos
China
The Second People's Hospital of Hunan Province
RECRUITING
Changsha
The Seventh People's Hospital of Hangzhou
RECRUITING
Hangzhou
3rd People's Hospital of Huzhou
RECRUITING
Huzhou
Shangdong Mental Health Center
RECRUITING
Jinan
Shanghai Mental Health Center
RECRUITING
Shanghai
Shanghai Tongji Hospital
RECRUITING
Shanghai
The First Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Tianjin Anding Hospital
RECRUITING
Tianjin
Xiamen Xianyue Hospital
RECRUITING
Xiamen
Zhumadian Psychiatric Hospital
RECRUITING
Zhumadian
India
Galaxy Superspeciality Hospital
RECRUITING
Aurangabad
Belagavi Institute of Medical Sciences - Belagavi
RECRUITING
Belgavi
All India Institute of Medical Sciences (AIIMS) - Bhopal
NOT_YET_RECRUITING
Bhopal
Society for Psychiatric Update and Research
RECRUITING
Chhatrapati Sambhajinagar
Graphic Era Institute of Medical Sciences and Hospital
NOT_YET_RECRUITING
Dehradun
Dharwad Institute Of Mental Health And Neurosciences
NOT_YET_RECRUITING
Dharwad
Career Institute of Medical Sciences and Hospital - Lucknow
RECRUITING
Lucknow
Dr. Ram Manohar Lohia Institute of Medical Sciences
RECRUITING
Lucknow
Mysore Medical College
NOT_YET_RECRUITING
Mysore
Assured Care Plus Hospital
RECRUITING
Nashik
Lifepoint Multispeciality Hospital
RECRUITING
Pune
Sowmanasya Hospital and Institute of Psychiatry
NOT_YET_RECRUITING
Tiruchirappalli
Deva Institute Of Healthcare Research
RECRUITING
Varanasi
Japan
Uematsu Mental Clinic
RECRUITING
Chikugo
Jimbocho Mental Clinic
RECRUITING
Chiyoda City
Horikoshi Mental Somatic Clinic
RECRUITING
Fukushima
Saitama Medical University Hospital
RECRUITING
Iruma
Rainbow and Sea Hospital
RECRUITING
Karatsu
Monzen-nakacho Mental Clinic
RECRUITING
Kōtō City
Suizenji Life Clinic
RECRUITING
Kumamoto
Kure Medical Center
RECRUITING
Kure
Hirota Clinic
RECRUITING
Kurume
Yutaka Clinic
RECRUITING
Sagamihara
Maynds Tower Mental Clinic
RECRUITING
Shibuya-ku
Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi
RECRUITING
Tokyo
Ikebukuro Olive Mental Clinic
RECRUITING
Toshima City
Yamagata Sakuracho Hospital
RECRUITING
Yamagata
Miki Mental Clinic
RECRUITING
Yokohama
Mexico
Scientia Investigacion Clinica S.C.
RECRUITING
Chihuahua City
Clinica de Investigacion en Reumatologia y Obesidad S. C.
RECRUITING
Guadalajara
B&B Investigaciones Medicas S.C.
RECRUITING
Mazatlán
Medical Care and Research SA de CV
RECRUITING
Mérida
Centro de Investigación Clinica Chapultepec
RECRUITING
Mexico City
Ketamine Clinic México
RECRUITING
Mexico City
Centro de Investigacion Clinica Chapultepec
RECRUITING
Morelia
Puerto Rico
SCB Research Center
RECRUITING
Bayamón
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-11-24
Estimated Completion Date: 2027-11
Participants
Target number of participants: 400
Treatments
Experimental: Brenipatide Dose 1
Brenipatide administered subcutaneous (SC) + SoC.
Experimental: Brenipatide Dose 2 .
Brenipatide administered subcutaneous (SC) + SoC.
Placebo_comparator: Placebo
Placebo administered SC + SoC.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov