If you qualify for the study, you will visit a study clinic in your area approximately 7 times over up to 13 weeks.
The Major Depression Studies are evaluating the effectiveness and safety of an investigational drug in combination with your current antidepressant therapy.
You may be able to take part in the Major Depression Studies if you:
Major Depression also known as Major Depressive Disorder (MDD) is not simply a change in mood, it is a medical condition that can cause emotional, physical, behavioral and cognitive symptoms.1
MDD is the most common form of depression; it manifests as a major depressive episode (which may be singular or recurrent) in which the affected individual experiences
It is estimated that Major Depressive Disorder (MDD) affects one in every fifteen adults yearly, and one in every six people will experience depression at one point in their lives.
MDD can happen to anyone at any time, but usually tends to affect those in their late teens to mid-twenties.2
There are different factors that are believed to contribute to depression including genetics (a family history of MDD or mental illness), chemical imbalances in the brain, difficult life events or traumatic events during childhood.
If left untreated, MDD can be a highly disabling, serious condition that is associated with significant morbidity and mortality.
If you or someone you know may be showing symptoms of depression, seek out professional medical advice for a proper diagnosis.
The Major Depression Studies are evaluating the effectiveness of an investigational medication for MDD, in combination with your current antidepressant therapy, on those that have had an inadequate response to antidepressants alone.
The Major Depression Studies will include approximately 1,500 patients, half of which will be in the USA.
Your participation in this study may last up to 13 weeks and will include 7 visits to a study clinic in your location. At these visits you will be given the study medications and undergo various assessments to evaluate your health. As the first step, you will be invited to visit a nearby study clinic where you will be given details about the study and complete any preliminary screening tests.
A clinical research study, or a clinical trial, is a study that helps to answer important questions about an investigational drug or device. For example, is the drug or device safe and effective? How does it compare with other drugs or devices?
These Major Depression Studies are evaluating the efficacy, safety, and tolerability of an investigational drug, cariprazine given in combination with your current antidepressant therapy, for those subjects that have had an inadequate response to antidepressants alone. It is taken as a capsule, once daily.
If you qualify to take part in the Major Depression Studies all study-related care will be provided to you at no cost. This includes all study-related tests, assessments, and visits. You will receive study-related evaluations throughout the study from a team of experienced doctors and nurses.
Volunteers who take part in the study may be compensated for their time and travel. Please discuss this with the study team when they contact you.
The research team will be able to explain more about what the Major Depression Studies will involve. Participation in the study is voluntary and it is up to you to decide if you want to take part. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without any penalty or loss of benefits to which you are otherwise entitled.
If you think you might like to participate in the Major Depression Studies or would like more information, please enter your information below so we can see if you may qualify and can contact you about the study. Keep in mind that participation is entirely voluntary. Even if you do decide to take part in this study, you may change your mind about participating at any time.
If you qualify, we will match you to a study clinic in your area that is seeking participants or notify you if one becomes available. They will contact you to explain more about the study before you make your decision about participating. You will attend an in-person visit where the study team will help determine if you qualify and if the study is right for you.