What is the purpose of the OARS 12 study?
The purpose of the OARS 12 clinical research study is to determine the safety and efficacy of an investigational medication. This investigational medication is being evaluated in adolescents with major depressive disorder (MDD) who have not responded well to their current antidepressant
About the OARS 12 study
The OARS 12 study is a phase 1b study currently enrolling adolescent patients with major depressive disorder (MDD). It aims to understand if an investigational medication is a safe and effective treatment for symptoms of MDD in adolescents when it is taken with their existing medication. This study will compare the effects of the investigational medication with a placebo. A placebo will look like the investigational medication, but does not contain any active medications.
What is Major Depressive Disorder (MDD)?
Depression is a common illness that negatively affects how a person feels, the way they think and how they act. Depression can cause feelings of sadness and/or a loss of interest in activities that they used to find fun. This can lead to various emotional and physical problems and can reduce a person's ability to go to school or be involved in daily activities at home.
Who can participate?
To participate in this study, your child must:
- Be 12 to 17 years of age
- Have been diagnosed with MDD
- Have not responded well to at least 1 but no more than 2 antidepressant treatments during the current depressive episode
- Have had at least 6 sessions of therapy in the current depressive episode
Additional eligibility criteria will be assessed by the study doctor or staff during the screening process prior to receiving any investigational medication. Not all children will qualify to participate in the OARS 12 study.
What should I expect if my child joins the OARS 12 study?
The first step is to see if your child may pre-qualify. If they do, and you would like to learn more about participating in the OARS 12 study, your information will be sent to the study center that you select. Study center staff will contact you to talk about the study and get more information about your child’s medical history. You and your child may be invited to the study center to take some tests.
If your child qualifies for the study the research doctor will talk to you about the risks and benefits of participation. After you understand and have had all of your questions answered you will sign a consent form. If your child is old enough and capable of understanding, they will be asked to sign an assent form. This means that they could be asked to actively agree to participate in the research study and assent to take part as well. If you or your child don’t understand what is expected of you, or what is expected of them, you should continue to ask questions and talk with the study doctor, your family, or others that you trust until you feel you understand.
Step 1 – Screening
This is the time when the study doctor and staff determine if your child is eligible, and you both decide if you want to participate. This step can take up to 4 weeks but may be shorter.
If you choose to enroll your child in the study, they will be asked to attend a screening visit. During this visit, your child will undergo tests and evaluations to determine if they are a good match for continuing in the study.
Step 2 – Study Medication Period and Follow-up
If eligible, your child will be in the study for up to 8 weeks (2 months) and visit the study doctor or clinical research staff approximately 6 times and receive 2 phone calls from the study doctor or staff. During participation in the study, your child will have health exams and tests and the study staff will ask your child how they are feeling. It’s possible your child may be asked to attend two additional study clinic visits. The study doctor or study staff will talk with you more about this.
Your child will be randomly assigned to 1 of the 2 study groups, and may receive a placebo (contains no active medicine) or the investigational medication. Your child has 75% chance of getting the investigational medication and 25% chance of getting the placebo. Neither you nor the study team will know which study group your child is in.
Your child will need to take the study medication (investigational or placebo) once a day at bedtime and as directed by the study doctor and visit the study center for appointments. In addition to the study medication, your child will continue to take the antidepressant medication they are currently taking for their MDD.
For additional information about clinical trials, in general, please see the FAQ-page of the website.
How can I help my child?
There is more information in the “Supporting a Loved One” section on what you can do and how you can support your child. If you are the parent or guardian of a child aged 12-17 and if they agree, it may be a good idea to complete the self-assessment with your child if you think this study might be right for them.
Short Study Summary
- Medical condition: Major Depressive Disorder (MDD)
- Participation duration: Around 12 weeks (3 months)
- Study locations: 10 research centers in the US
- Phase: 1b