A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability or Aticaprant 10 mg as Adjunctive Therapy in Adult Participants with Major Depressive Disorder (MDD)
We are conducting an investigational medication clinical trial to test the efficacy of the medication, Aticaprant, as an add-on treatment to current antidepressant treatment to help improve mood symptoms in participants with Major Depressive Disorder.
Who should join the clinical trial?
The Department of Psychiatry and Neurobehavioral Sciences seeks men and women who:
- are 18-74 years old
- are currently experiencing a major depressive episode and have been diagnosed with recurrent or single episode Major Depressive Disorder
- have had an inadequate response to at least 1 antidepressant treatment
What will the clinical trial involve?
The clinical trial will involve up to 10 study visits, partially in-person and partially remote contact, that will last approximately 3 months. Completion of the full study will consist of 2 screening visits, 7 treatment visits, and 1 follow-up visit.
The screening visits will involve collection of medical history, psychiatric history, and clinical laboratory tests (blood work, urinalysis, and alcohol/drug testing) as well as completion of mood and safety assessments (physical exam, safety questionnaires, ECG, and cognitive testing) in order to determine eligibility.
If eligible, you will be randomly assigned to receive either the investigational medication (Aticaprant) or a placebo pill. Neither you nor the researchers will know which you are receiving. At the treatment visits, you will complete similar assessments as done at screening (blood work, mood/efficacy/safety assessments, physical exam, and ECG).
Finally, you will attend a follow-up visit consisting of a physical exam and mood questionnaires.
All study-related procedures will be provided free of charge. This is not a paid clinical trial. However, you will receive a stipend up to $625 to help cover incidental or transportation-related costs.
Additionally, if you fully complete the treatment phase according to protocol, you will have the option to enter a long-term, open-label trial of Aticaprant instead of completing the follow-up visit. This would allow you to receive the investigational medication, Aticaprant, for an entire year.
Interested in participating?
Click here to contact us about participating.
For more information or questions about the study, contact the study coordinator listed below.
Kayla Pennycuff, Clinical Research Coordinator