Major Depressive Disorder

The purpose of this trial is to evaluate how effective an investigational study drug used in addition to existing antidepressant treatment is in treating the symptoms of MDD.  Researchers want to compare the investigational drug to placebo, which looks like the investigational drug but contains no active ingredients. In this study, the term “study drug” refers to either the investigational product or placebo.

The investigational drug has not been approved by any regulatory authority for the treatment of MDD.

Clinical Trials Listing: https://clinicaltrials.gov/study/NCT06633016

You will be asked to take the study drug once daily for 6 weeks, along with your ongoing antidepressant treatment. Participation will last up to 13 weeks. During this time, you will be asked to meet with our study team up to 9 times to provide feedback about your experiences. You will be compensated for your time and travel to attend these visits. They will also perform study procedures to evaluate your wellbeing, including physical exams and taking vital signs.

During the screening period, which will occur over a period of up to 5 weeks, the study team will ask participants some questions and do some tests to see if they are eligible for the study. Participants will be informed if they are taking any medications that would need to discontinue, or are not allowed in the study.

A placebo is a liquid-solution that looks like the study drug but contains no active ingredients.

This study is double-blind, which means that neither participants nor the study team will know whether they are taking the study drug or placebo during the study.

A safety follow-up visit will occur 2 weeks after the treatment period is completed. During this period of the study, participants will have a visit at the clinic for some tests and procedures.

The results of this study will provide more information about the investigational drug and whether it could one day be used to treat MDD. While you may not personally benefit from study participation, you could contribute information that helps people with MDD in the future.

It is also possible you could experience side effects while in this study. Before you begin, the study staff will review a full list of risks and possible side effects with you. During the study, you will be closely monitored for any side effects related to your study participation.  

• Must be between 18 and 65 years of age and meet the DSM-5 criteria for a diagnosis of MDD.
• You are experiencing a moderate or severe major depressive episode of up to 12 months.
• You have been using a SSRI or SNRI antidepressant for at least 6 weeks and are having an inadequate response.
• You do not have a history of obsessive-compulsive disorder (OCD), posttraumatic stress disorder (PTSD), panic disorder, or eating disorder, according to DSM-5 criteria.

​Additional criteria will apply. All study-related visits, tests, and investigational drugs will be provided at no cost. You may also be reimbursed for study-related travel expenses. 

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Please complete the form linked below, and a member of our study team will reach out to you.