Living with depression that hasn't improved with antidepressants?
Learn more about a research study of an investigational drug for adults who have been diagnosed with major depressive disorder(MDD) and have used an antidepressant medication without sufficient improvement in their depression symptoms.
If you're eighteen to sixty-five and haven't found relief with one to three antidepressants, you may be eligible to participate.
What is the purpose of this study?
In this study, doctors want to evaluate the safety and effectiveness of an oral investigational drug when it is combined with an approved antidepressant treatment.Researchers want to compare the investigational drug to placebo, which looks like the investigational drug but contains no active medication. In this study, the term “study drug”refers to either the investigational medication or placebo.
The investigational drug is not approved to treat MDD. Only peoplewho participate in a research study like this one can receive it. Youmay not directly benefit from participating in this study. However, the results of this study will provide more information about the investigational drug and whether it could one day be approved to treat MDD when combined with antidepressant treatment.
Who is eligible to participate in this study?
To pre-qualify for this study, you must:
- Be 18 to 65 years of age
- Have been diagnosed with MDD and currently are experiencinga depressive episode
- Have used at least 1 but not more than 3 antidepressantmedications in your current depressive episode withoutsufficient improvement in your depression symptoms
Additional criteria will apply. All study-related visits, tests, anddrugs will be provided at no cost. You may also be reimbursed forstudy-related travel expenses.
What will happen during this study?
If you are eligible and agree to participate, you will take your study drug and antidepressant treatment once a day for 14 weeks. The study doctor/staff will talk with you about the antidepressant treatment you receive, which will be based on your antidepressant treatment history.
Your total study participation could last up to 19 weeks (about 5months). This includes screening for eligibility, study dosing, and follow-up. You will also be asked to attend up to 15 study clinic visits for tests and assessments.
What are the benefits and risks related to this study?
It’s possible you could benefit from study participation, but thiscannot be guaranteed. However, your study participation couldhelp people with MDD in the future.You may also experience one or more side effects during thisstudy. Prior to you beginning study participation, the study staff will review known study-related risks and side effects with you.Throughout the study, you will be closely monitored for any study related side effects or changes in your health.