This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms. The trial is divided into three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,000
Administered SC
Administered SC
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)
Time frame: From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months
Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2
Time frame: Baseline, Up to at Least 6 Months
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline, Up to at Least 6 Months
Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score
Time frame: Baseline, Up to at Least 6 Months
Change from Baseline in Patient Global Impression of Severity (PGI-S)
Time frame: Baseline, Up to at Least 6 Months
Change from Baseline in Generalized Anxiety Disorder (GAD) - 7 Total Score
Time frame: Baseline, Up to at Least 6 Months
Change from Baseline in Patient Rated Symptom and Disease Severity
Time frame: Baseline, Up to at least 6 months
Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score
Time frame: Baseline, Up to at Least 6 Months
Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2 and on an Atypical Antipsychotic
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Accellacare - Moorpark
Moorpark, California, United States
ATP Clinical Research
Orange, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Encore Medical Research
Hollywood, Florida, United States
K2 Medical Research - Maitland
Maitland, Florida, United States
Life Medical Research Group Corp
Miami Gardens, Florida, United States
CLA Research
Naples, Florida, United States
Optimal Research Sites
Orange City, Florida, United States
Charter Research - Orlando
Orlando, Florida, United States
K2 Medical Research - Tampa
Tampa, Florida, United States
...and 175 more locations
Time frame: Baseline, Up to at Least 6 Months
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Time frame: Predose Up to at Least 6 Months
Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADA)
Time frame: Baseline Up to at Least 6 Months
Change from Baseline in Patient-Reported Outcomes Measurement Information Systems (PROMIS) Short Form
Time frame: Baseline, Up to at Least 6 Months