This study evaluates the safety and how well it works of brenipatide when administered with standard of care (SoC) compared to dummy treatment (placebo) plus SoC in delaying the return of major depressive symptoms. The trial is divided into four periods as follows: a screening period that will last approximately 1 month, a treatment period with a potential post treatment period that combined will last a minimum of 12 months, and the follow up period that will last approximately 2 months.
Official registry: https://clinicaltrials.gov/study/NCT07412756 · Eli Lilly and Company · enrollment listed as 1,000
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
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 evaluates the safety and how well it works of brenipatide when administered with standard of care (SoC) compared to dummy treatment (placebo) plus SoC in delaying the return of major depressive symptoms.
They plan to enroll about 1,000 people at 180 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
A Phase 3, 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 Major Depressive Disorder (RENEW-MDD 1)
Interventions: Brenipatide, Placebo
Primary outcome (registry wording): Time to Relapse Defined as the Number of Days from Randomization to Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD)
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.
+ 148 sites outside the US on the same record
Study Description: This study examines relations between neurocognitive and clinical features of pediatric anxiety disorders. The study uses neuro-cognitive tasks, functional magnetic resonance imaging (fMRI), as well as magneto- and electro-encephalography (M/EEG).
NCT00018057 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)
Background: There are no good treatments for people considering suicide. Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies.
NCT02543983 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)
The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2.
NCT02649985 · Official ClinicalTrials.gov record · Brigham and Women's Hospital
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 3. 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