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Major Depressive Disorder

 Although there are treatments available for your major depressive disorder (MDD), you haven’t found one that consistently manages your depressive symptoms. As you continue to experience these symptoms and depressive episodes, you may be considering additional options for your MDD.  

About This Study

The Boehringer Ingelheim 1447-0005 Trial is looking at how well a potential new medication (investigational trial drug) works for people living with Major Depressive Disorder (MDD).

  

Depression is a common mood disorder that causes feelings of sadness and loss of interest.
It can affect your ability to work and manage everyday activities. If you have moderate-to-severe symptoms, which are common with MDD, the burden on you and your family or carers can be high.


In this study, doctors want to evaluate the safety and effectiveness of an oral investigational drug. Researchers want to compare the investigational drug to placebo, which looks like the investigational drug but contains no active medication. 


The investigational drug is not approved to treat MDD. Only people who participate in a research study like this one can receive it. You may 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.


Clinical Trials Listing: https://clinicaltrials.gov/ct2/show/NCT05593029

Interested in Participating?

Sign Up

What Will Happen During This Study?

This trial is being carried out to:

  • see how well the trial drug works for people living with MDD, when given with existing medicines for depression (antidepressants)
  • confirm how safe the trial drug is.


This is a Phase 2 trial. This means the trial drug has been tested in people living with MDD, and now will be tested in a larger group of people.


If you take part, you will:

  • be in the trial for up to 11 weeks
  • visit the trial center up to 7 times
  • take either the trial drug or placebo (both referred to as the “trial medication” – a placebo looks the same as the trial drug but contains no active medication)
  • continue to take your usual antidepressants and having therapy as usual.

What Are The Benefits and Risks Related to This Study?

It’s possible you could benefit from study participation, but this cannot be guaranteed. However, your study participation could help people with MDD in the future. 


You may also experience one or more side effects during this study. 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. 

Who is eligible to participate in this study?

Key Entry Criteria:

  • Are between 18 and 65 years of age 
  • Have been diagnosed with MDD and currently are experiencing a depressive episode 
  • Your depressive symptoms have been ongoing for at least 8 weeks


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

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

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