Around the world, depression affects
hundreds of millions of people. If you have
depression and are taking antidepressant
medication but still have symptoms, the
VENTURA-5 study may be an option for you.
The main purpose of this study is to evaluate the efficacy and safety of a once daily oral study medication. Study doctors want to learn if the study medication may delay the return of depressive symptoms in adults
who have inadequately responded to antidepressant medications in their current episode of depression.
The study medication is investigational, which means it is not approved by regulatory health authorities. It is only available to people with depression who agree to be in this study. This study will help doctors and researchers determine if the investigational study medication could one day be available to people with depression.
You may be able to participate in this study if you:
• Are 18 to 64 years old
• Have been diagnosed with depression
• Are experiencing depressive symptoms, including a loss of interest or the ability to feel pleasure, despite currently taking antidepressant medication.
What will happen during the VENTURA-5 study?
If you agree to participate in the study, you will receive the investigational study medication for up to 16 weeks. You may then be randomly assigned (like the flip of a coin) to take either the investigational study medication or placebo. This will occur in the blinded phase of the study. During this time, you will not know if you are receiving the investigational study medication or placebo.
Placebo looks like the investigational study medication but contains no active medication. You have an equal chance of receiving the investigational study medication or placebo.
There are 5 phases in the study:
• Screening phase (up to 4 weeks)
• Initial study treatment phase (6 weeks)
• Extended study treatment phase (10 weeks)
• Blinded study treatment phase (length will differ for each participant)
• Follow-up phase (2 weeks)
The number of phases and amount of time in the study will differ for each participant.
During your study participation, you will be asked to:
• Take your study medication (investigational or placebo) once a day during all study treatment phases
• Continue taking your current antidepressant medication throughout all study phases
• Attend regularly scheduled visits in person and over the phone or video conference
There is no cost to participate in this study. All study-required visits, tests, and study medication will be provided to you. You may also be reimbursed for study-required travel costs and meals.
What are the benefits and risks related to the VENTURA-5 study?
You may or may not benefit from participating in the study. However, your study participation may help people with depression in the future.
You may experience one or more side effects during this study. Before you begin the study, the study team will go over any known study-related risks and side effects with you.
You will be closely monitored for any study-related side effects or changes in your health while you are in this study.
Do I have to participate in the VENTURA-5 study?
No, it is your choice to participate in this study. Even if you agree to participate, you are free to stop being in the study at any time and for any reason.
Your decision about participating in this study will not affect your regular medical care. You may choose to talk with your doctor, family, and friends about whether this study could be right for you.
Enroll for VENTURA-5 study now.