Summary:
Major depressive disorder (MDD) is more than just feeling a little sad or having a rough day. If you have MDD, your feelings of sadness can last a long time.
It’s not just an adult thing — children and adolescents can have MDD too. Clinical research studies like STEADi (Study To Evaluate an Adolescent Depression Investigational drug) are done to find out if investigational drugs are safe to treat MDD and to see if they work in children and adolescents.
Why is the STEADi clinical research study being done?
The purpose of the study is to find out if an investigational drug is safe and to see if it works for adolescents who have MDD.
What is the investigational study drug?
The investigational drug being studied is approved by the U.S. Food and Drug Administration and available by prescription as a treatment for adults with depression. It is not approved as a treatment for children or adolescents with depression; it is considered investigational because we are testing the safety and efficacy of this investigational drug in adolescents in this clinical research study.
How long will the study last?
The study will last for about 10 weeks. A parent or consenting caregiver will need to come to the study doctor’s office about 9 times.
What will happen during the study?
If the study doctor determines that your child meet the requirements to join the study, he or she will then be randomly assigned (by chance) to either take the active study drug or a pill that has no active study drug in it, called a placebo. At the study visits, there will be procedures to check your child’s health and to see how your child’s body is responding to the study drug he or she has been assigned. At some visits, your child will also have blood and urine tests.
Who can be in the study?
Girls and boys who are 12 to 17 years old and have been diagnosed with MDD or who have been feeling depressed for at least the past 6 weeks may be eligible to participate in the study.
Why should my child and I consider the study?
There is no way to know if participating in this study will help MDD. This study will help doctors learn more about the investigational study drug and if and how it affects adolescents with MDD, which may improve treatment options for adolescents with MDD in the future. About 500 adolescents will take part in the study, which is being done at about 60 study centers across the United States.
Before choosing to take part in the clinical research study, read all the information the study doctor provides and ask questions about the study. The study doctor can answer any questions you may have about study procedures or potential risks and benefits of study participation.