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GOLDILOKs™ PRISM

There is no one-size-fits-all treatment for depression. Every teen and their depression are unique. Many teens’ depression symptoms improve with antidepressant medicine, therapy, or both.  Unfortunately, it can take several weeks to know if antidepressant medicines, such as fluoxetine (Prozac®), are working, and some teens’ depression symptoms do not get better with this medicine.

GOLDILOKs™ PRISM is a research study designed to understand why fluoxetine (Prozac®) works for some teens with depression and not for others.

The study team wants to use this information to try to predict whose depression is likely to get better with fluoxetine and whose is not as soon as possible. What we learn from this study could help the care team find the right treatment sooner and put teens on a quicker path to recovery.

We are inviting teens ages 12 to 18 who are starting fluoxetine (Prozac®) for depression and their parents/guardians to participate. Scroll down to learn more.

About the Study

Teens ages 12-18 diagnosed with depression are invited to join this study.

To be eligible, participants must be prescribed fluoxetine (Prozac®) to treat depression, but they have not started the medicine yet

This study lasts 3 months.

There are 4 total visits. Each time, we’ll ask you to:

  • Fill out surveys and answer questions about your depression symptoms.

  • Give a urine sample.

  • Have your blood drawn.

The first visit will last about 2-3 hours. We will ask you to wait to start your medicine until this visit is over. If you qualify for the study, we’ll give you a Garmin smartwatch to wear every day. After this visit, you can start taking fluoxetine (Prozac®) as your health care provider prescribed.

The last 3 visits happen every few weeks over the next 2-3 months. These visits will last between 30 minutes to 1 hour.

PRISM Study timeline.png

The first visit happens in the Pediatric Clinical Research Unit (PCRU) at the Children’s Mercy Adele Hall Campus in downtown Kansas City.

The last 3 visits can happen at a Children’s Mercy location that is convenient for you and your family, depending upon availability. Available locations include Children’s Mercy East, Northland, Broadway, Kansas, or Adele Hall.

If you complete all the study visits, you will receive headphones, $220, and get to keep the Garmin smartwatch.

Contact Us to Learn More

For more information or to talk about enrolling, contact the study team at Children’s Mercy directly:

(816) 731-7326

Contact Us by Email



You can also fill out this interest form and a study team member will contact you:

Interest Form

 

Research is always voluntary. Your decision to participate or not will not affect your care at Children’s Mercy in any way.

Parent/Caregiver FAQs

No. Fluoxetine (Prozac®) is a medicine used to treat depression. It is approved by the Food and Drug Administration (FDA) and has been used to help treat depression in teens for almost 20 years.

Not all teens need medicine to treat their depression. When a teen does need medicine, many health care providers try this medicine first. We are studying fluoxetine (Prozac®) because it only works for some teens, and we want to understand why.

Your teen’s regular health care provider or a specialist will prescribe fluoxetine (Prozac®). They will see your teen for regular clinic visits throughout the study to see how the medicine is working, change the dose, or stop the medicine, if needed.

If you and your teen are still looking for care for your teen’s depression, please reach out to your primary care provider (PCP). They may diagnose and treat your teen or refer you to a specialist such as a psychiatrist or Adolescent Medicine provider. If you, your teen, and provider decide to treat your teen’s depression with fluoxetine (Prozac®), you may enroll in the study. 

For more information on available resources, please visit the Children's Mercy Mental Health in Children and Adolescents and Adolescent Medicine webpages. 

Yes, teens can start or continue to receive therapy or counseling during the study.

Teens who participate in this study must wait to start fluoxetine until after they finish the first study visit.  The study team will make every effort to schedule this visit as soon as possible, typically within a few days.

While you are deciding whether to participate, consider whether waiting a few days to start fluoxetine fits with your and your family’s plan for treating your depression. Also, talk to your teen’s health care provider to help you decide if waiting to start the medicine is okay for your teen.   

We are happy to work with you to try to minimize any disruptions and to schedule visits on days or times of the day when school is not in session.

There are no extra costs for being in this study. The cost of the medicine and regular clinic visits your teen has with their health care provider are not paid for the by study. These are part of the regular care that teens who are not in this study receive.  

There’s a small risk of loss of privacy, and some questions we ask may be uncomfortable or embarrassing for your teen. Participants do not have to give any information that they do not want to give. Also, the blood draw may be uncomfortable or cause a bruise, but participants can have numbing cream to help with any pain.

There is no direct benefit to your teen. But by being in this study, they may help the study team find better treatments for people with depression in the future.

Antidepressant medicines, including fluoxetine, take several weeks to a few months to know if they work well or not. Health care providers often try one antidepressant medicine for up to 3 months before changing to a different one. This study is set up to last the same amount of time.

What is GOLDILOKs™?

GOLDILOKs™ stands for Genomic and Ontogeny-Linked Dose Individualization and cLinical Optimization for KidS.  This is a program at Children’s Mercy to help guide the health care team to find the right medicine at the right dose that is not too big, not too small, but just right for each child to treat their disease or symptoms.

Learn more about the GOLDILOKs program.