Testing Brenipatide against a placebo for major depressive disorder
Official title: A Study of Brenipatide in Adult Participants With Major Depressive Disorder
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
Administered SC
Placebo
Administered SC
Canadian Sites (14)
Heritage Medical Research Clinic
Calgary, Canada
Premier Clinical Trial Network
Hamilton, Canada
Kelowna Health and Memory Centre
Kelowna, Canada
Alpha Recherche Clinique - Lévis
Lévis, Canada
Genge Partners
Montreal, Canada
Dar Clinical Research - Ottawa
Ottawa, Canada
Centre de Recherche Saint-Louis inc.
Québec, Canada
Alpha Recherche Clinique
Québec, Canada
ALPHA Recherche Clinique
Québec, Canada
Richmond Clinical Trials
Richmond, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Canada
Diex Recherche Sherbrooke
Sherbrooke, Canada
Centre for Neurology Studies
Surrey, Canada
Maple Leaf Research
Toronto, Canada
Eligibility Criteria
See who this study is looking for18 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Meet the diagnostic criteria for major depressive disorder
- +Are on a stable standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → 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
- −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Brenipatide, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 4 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 75 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,000 people.
The study is currently expected to finish around February 2028.
The main measurement is taken over: From RandomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → in Double-BlindDouble-blindNeither you nor the study team knows which group you are in.Read more → Adjunctive Treatment to First Relapse For at Least 12 Months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Time to Relapse Defined as the Number of Days from RandomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD) — measured over From Randomization in Double-BlindDouble-blindNeither you nor the study team knows which group you are in.Read more → Adjunctive Treatment to First Relapse For at Least 12 Months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07412756 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About BrenipatideDrug
Administered SC
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Administered SC
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 75 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 75 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From RandomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → in Double-BlindDouble-blindNeither you nor the study team knows which group you are in.Read more → Adjunctive Treatment to First Relapse For at Least 12 Months.
The study as a whole is currently expected to finish around 2028-02.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,000 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 15 locations, including: Calgary, Canada; Hamilton, Canada; Kelowna, Canada; Lévis, Canada; Montreal, Canada; Ottawa, Canada, and 9 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (3)
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
Adams Clinical Harlem
New York, New York, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.