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A Study for Adult Participants With Major Depressive Disorder

Enrolling at: Sarnia · Hamilton
Phase 3Study phase
≈12 monthsStudy length
18–75Age range
2 sitesResearch locations

About this study

Interested in Participating in a Clinical Trial for Adults Suffering from Major Depressive Disorder (MDD)?

This clinical research study is looking at the safety and effectiveness of an investigational medication option for people who suffer from major depressive disorder.

This study evaluates 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.

Would you like to take part?

As a volunteer in a research study, you’ll receive medical care related to the study from the study doctor, and regular follow up to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the experimental medication being studied will be of benefit to others or not. Study volunteers are an important part of moving medical care forward.

Who may qualify

You may qualify if
  • 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 be 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-injecting study intervention
    • storing and using the provided blinded study intervention, as directed
    • maintaining electronic and paper study diaries, as applicable, and
    • completing the required questionnaires
This study may not be a fit if
  • 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.
  • Show 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
Every study has additional criteria the research site will review with you.

What participation may involve

  • Regular visits with the study team at no cost
  • Study assessments and health monitoring throughout
  • Check-ins between visits
  • Informed consent before anything begins — questions welcome
Time commitment: ≈12 months — confirmed by the research site. The full visit schedule is explained during informed consent.

What participants may receive

  • Study-related care from a physician-led team
  • Study assessments at no cost
  • Reimbursement for reasonable travel, where applicable
Specifics vary by study and site, and are never a guarantee of benefit. Being in a study is not a substitute for regular medical care.
Participating research sites

Where this study is enrolling

SARNIA, ONBluewater Clinical Research GroupPrincipal investigator: Dr. John O’Mahony, Dr. Sean PetersonView site →HAMILTON, ONWinterberry Family MedicinePrincipal investigator: Dr. Steven V. ZizzoView site →

Learn more

About the condition

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Common questions

Do I have to decide now?
No. Answering the questions is not a commitment — it simply lets the research team see whether this study may be appropriate and contact you to talk it through.
Will it cost me anything?
No. Study visits and study assessments are provided at no cost, and reasonable travel may be reimbursed where applicable.
What happens after I submit the form?
A member of the research team reviews your answers and contacts you — usually within two business days — to answer questions and review the next steps.
Could I receive a placebo?
Some studies compare a treatment with a placebo. Whether this study does is explained clearly during informed consent, before you decide anything.
Can I leave the study after it starts?
Yes. Participation is always voluntary. You can withdraw at any time without giving a reason and without it affecting your regular medical care.
Request contact

Ask the research site to contact you

Your answers go only to the research site, help the team prepare before they call — and completing the form doesn’t obligate you to take part.
JAS Study Interest (Stream A)

See if you may qualify

A few quick questions — about a minute. Your answers help the research team prepare before they contact you.

For anyone under 18, a parent or legal guardian should complete this form and would need to consent on their behalf.

See if you may qualify →

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