Depressive Disorder, Major
Conditions
Keywords
Major Depressive Episode, Mood Disorders, Depression, Depressive Disorder
Brief summary
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.
Interventions
DRUGBrenipatide
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Meet the diagnostic criteria for major depressive disorder * Are on a stable standard of care medication for major depressive disorder * 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
Exclusion criteria
* Have a lifetime history or current diagnosis of the following: * schizophrenia or other psychotic disorder * bipolar disorder * borderline personality disorder, or * any eating disorder. * Have type 1 diabetes mellitus, or a history of * ketoacidosis, or * hyperosmolar state or coma. * Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening * Are actively suicidal or deemed a 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months |
Secondary
| Measure | Time frame |
|---|---|
| Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2 | Baseline, Up to at Least 6 Months |
| Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Baseline, Up to at Least 6 Months |
| Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score | Baseline, Up to at Least 6 Months |
| Change from Baseline in Patient Global Impression of Severity (PGI-S) | Baseline, Up to at Least 6 Months |
| Change from Baseline in Generalized Anxiety Disorder (GAD) - 7 Total Score | Baseline, Up to at Least 6 Months |
| Change from Baseline in Patient Rated Symptom and Disease Severity | Baseline, Up to at least 6 months |
| Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score | 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 | Baseline, Up to at Least 6 Months |
| Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide | Predose Up to at Least 6 Months |
| Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADA) | Baseline Up to at Least 6 Months |
| Change from Baseline in Patient-Reported Outcomes Measurement Information Systems (PROMIS) Short Form | Baseline, Up to at Least 6 Months |
Countries
Australia, Brazil, Canada, China, Germany, Greece, Japan, Mexico, Poland, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed