This study wants to assess the how well it works and safety of brenipatide when administered with standard of care (SoC), compared with dummy treatment (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.
Official registry: https://clinicaltrials.gov/study/NCT07286175 · Eli Lilly and Company · enrollment listed as 400
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are Brenipatide, or Placebo. The registry lists allocation as randomized. This study wants to assess the how well it works and safety of brenipatide when administered with standard of care (SoC), compared with dummy treatment (placebo) plus SoC in delaying the worsening of bipolar disorder symptoms.
They plan to enroll about 400 people at 87 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
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)
Interventions: Brenipatide, Placebo
Primary outcome (registry wording): Time to Relapse Defined as Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 67 sites outside the US on the same record
This study wants to use eye-tracking technology to study attentional biases, reward sensitivity, and cognitive control in adult patients with bipolar disorder with or without anxiety and/or substance use disorder comorbidity.
NCT03829787 · Official ClinicalTrials.gov record · University Hospitals Cleveland Medical Center
Background: More than 12,000 people have taken part in research at the Experimental Therapeutics \& Pathophysiology Branch at the National Institute of Mental Health Intramural Program. This has led to advances in the treatment of depression, bipolar disorder, and suicide risk.
NCT04877977 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)
Background: Mood disorders, such as bipolar disorder, can have serious effects on a person s life. People with bipolar disorder are more likely to have heart disease and abuse substances.
NCT05669703 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary