OARS 12 Research Study For Adolescents With Major Depressive Disorder (MDD)

• Too many adolescents continue to struggle with depression, despite treatment. This study is evaluating the safety and effects of an investigational medication for adolescents who have been diagnosed with MDD and have not responded well to their current antidepressant. The investigational medication has been studied in more than 1,000 adult patients and healthy volunteers, but it has not been studied in adolescents. The investigational medication is not approved to treat MDD, and it is only available to adolescents with MDD in research studies like this one.
• In this study, the investigational medication will be compared to placebo, which looks like the investigational medication but contains no active ingredients. Eligible patients will be randomly assigned (by chance) to 1 of 2 study groups. One group will receive the investigational medication, and the other group will receive placebo. There is a 75% chance of receiving the investigational medication and a 25% chance of receiving placebo. All patients in this study will take their study medication (investigational or placebo) once a day before bedtime for about 6 weeks. Additionally, patients will continue taking their current antidepressant medication throughout the study.
• Total participation in this study will last approximately 12 weeks (3 months), which includes up to 7 study clinic visits for health exams and tests, as well as 2 phone calls from the study doctor/staff. Patients may also be required to attend two additional study clinic visits. The study doctor/staff will talk with you more about this.
• All study-required visits, tests, and study medication will be provided at no cost. In addition, reimbursement for study-required travel may be available. To learn more about this study, contact Brooke Rivera, Clinical Coordinator, Yale Pediatric Depression Lab at (203) 974-2241 or email PediDepression@yale.edu.

To pre-qualify for this study, your child must: