About Clinical Research

Clinical research studies are done to test investigational drugs for diseases and conditions. Studies help determine if investigational drugs are safe to use and work to improve the health of people. Before any drug can be approved and made available to the general public, it has to go through several phases of clinical research.

Conducting clinical research studies in children is important to assess the safety and effectiveness of investigational drugs in children and adolescents.

Why do people participate in studies?

People participate in clinical research studies for a variety of reasons. Some volunteers may participate in studies because they want to learn more about their disease. Others volunteer to participate because they want to help researchers learn more about a disease so that it may help them and others in the future.

What if I have questions during a study?

You and your child can ask questions of the study staff at any point before, during, and after the study. Before agreeing to participate, please make sure that you and your child understand the responsibilities of study participants and parents. If you have any concerns about your child participating in the study, you should feel comfortable discussing them with a member of the study staff at any time.

Can my child leave a study once it has started?

Study participation is completely voluntary, and you can end your child’s participation at any time, for any reason. If you think you would like your child to stop participating in a study, talk to the study doctor. If you decide your child should leave a study early, the study doctor may ask that he or she return to the study site for a final visit, but there will be no negative impact on the care your child receives.

Can my child see other doctors during a study?

You can visit any doctor to meet your child’s needs during a study. Please let the study doctor know that you will be seeing another doctor and if any medication is prescribed during the visit.

About the Studies

The Engage clinical research studies are for children and adolescents with major depressive disorder (MDD). The purpose of the studies is to find out if two different investigational drugs are safe and effective for children and adolescents who have MDD.

Participants may only participate in one of the following studies at a time. You can complete the pre- screening questionnaire on this website to determine in which study your child may be eligible to participate.

Engage 11

Who can participate?

Your child may be able to join the Engage 11 clinical research study if he or she:

  • Is aged 12 to 17
  • Has been diagnosed with MDD or has been having feelings of depression

How long will the study last?

If your child is eligible for the Engage 11 clinical research study, his or her participation will last approximately 10 weeks, including 9 visits to the study site.

Engage 22

Who can participate?

Your child may be able to join the Engage 22 clinical research study if he or she:

  • Is aged 7 to 17
  • Has been diagnosed with MDD or has been having feelings of depression for at least the past 6 weeks

How long will the study last?

If your child is eligible for the Engage 22 clinical research study, his or her participation will last approximately 10 weeks, including 9 visits to the study site.

If your child completes the Engage 22 study, he or she may be eligible to enroll in the Engage 23 clinical research study, during which all study participants will receive the investigational drug.

Engage 23

Who can participate?

Your child may be able to join the Engage 23 clinical research study if he or she:

  • Is aged 7 to 17
  • Has been diagnosed with MDD or has been having feelings of depression for at least the past 6 weeks

How long will the study last?

If your child is eligible for the Engage 23 clinical research study, his or her participation will last approximately 28 weeks, including 17 visits to the study site.

What are the study drugs?

There are two different investigational drugs being evaluated in the Engage clinical research studies. Some participants in Engage 11 and Engage 22 may receive placebo or an approved drug instead of an investigational drug. Placebo looks like the investigational drug but has no active drug.

In Engage 11, the investigational drug is in a class of drugs knows as serotonin-norepinephrine reuptake inhibitors (SNRIs).

In Engage 22 and 23, the investigational drug is in a class of drugs knows as selective serotonin reuptake inhibitors (SSRIs ).

What will happen during the studies?

If your child is eligible and agrees to participate in any of the Engage clinical research studies, he or she will be required to:

  • Visit the study site as directed. At these visits, your child will have study-related tests and procedures.
  • Take the study drug as directed by the study doctor.
  • Have blood and urine tests.
  • Have a designated caregiver willing to attend all visits and provide information about the child’s health.
  • Tell the study staff if he or she is not feeling well.

About Depression

Depression is more than just feeling a little sad or having a rough day. For someone with depression, the feelings of sadness can last a long time. Depression can affect children and adolescents of all ages.

Young people with depression may show symptoms that seem different from adult symptoms. Children and adolescents who have depression may complain that they don’t feel well, may refuse to go to school, or may worry that a loved one may leave or die. Sudden changes in weight or in sleep patterns may also be signs of depression. Older teenagers may get into trouble at school or show reduced interest in activities they used to enjoy, such as playing sports or spending time with friends.

According to the journal Child and Adolescent Psychiatric Clinics of North America, it is estimated that approximately 1 percent to 2 percent of children and 3 percent to 8 percent of adolescents have depression. Although there are a number of treatment options available for pediatric depression, including medication and psychotherapy, there remains a need for continued research. Clinical research studies like the Engage studies are done to evaluate the potential safety and effectiveness of new investigational drugs for children and adolescents with depression.