Clinical Research Study for Children and Teens with Bipolar I Depression
A research study exploring a potential treatment for children and teens (ages 10-17) living with bipolar I depression. Up to $2,000 in family compensation and free round-trip Uber to every visit.
Could This Study Help Your Child?
Who Qualifies?
- Your child has been diagnosed with bipolar I disorder
- Your child is between 10 and 17 years old
- Your child is currently in a depressive episode (lasting at least 2 weeks, no longer than 12 months)
- You are willing and able to accompany your child to all study visits
- Your child is not currently pregnant, nursing, or using substances
As a Parent, You've Seen It:
- The sadness that won't lift, no matter what you try
- Loss of interest in friends, hobbies, and school
- Sleeping too much - or barely at all
- Irritability and withdrawal from the family
- Frustration when other treatments haven't been enough
This study is specifically designed to evaluate a potential treatment for these symptoms in children and teens.
A Closer Look at the Study Medication
This is an investigational pediatric study for bipolar I depression.
About Cariprazine
About the Study Medication
Cariprazine is a medication already FDA-approved for bipolar depression in adults. It works differently from many existing medications. Its safety and effectiveness in children under 18 has not been established, which is why this research study is being conducted.
What Families Should Know
This study is randomized, double-blind, and placebo-controlled, with a 50/50 chance of receiving cariprazine or placebo. Participation is voluntary, there is no guarantee of therapeutic benefit, and results cannot be predicted.
Already Studied in Adults
Cariprazine is FDA-approved for bipolar depression in adults.
This pediatric study is investigating whether it may also help children and teens with bipolar I depression.
Weight- and Age-Based Dosing
Your child takes 1 capsule daily for 6 weeks, with dose based on age and weight.
Dosing ranges from 0.75-1.5 mg/day for younger or lighter children and 1.5-3.0 mg/day for older teens.
Close Monitoring & Safety
Your child will have regular psychiatric evaluations, vital signs checks, lab work, and ECGs throughout the study.
The study doctor is available 24/7 at (404) 999-2734.
Possible Long-Term Study
Children who complete all 13 weeks may be eligible for a separate long-term safety study.
Participation is voluntary and availability depends on open enrollment.
About Dr. Maria E. Johnson
Principal Investigator
Dr. Johnson has spent 15 years caring for people with bipolar disorder and leading mood disorder research. "Bipolar depression in children is often misunderstood and undertreated," she says. "We're committed to finding safe, effective options for young people and their families."
Board Certified
Psychiatry
Mood Disorder Expert
15 years of bipolar care and research
Pediatric Focus
Dedicated to advancing treatment for children and teens
"No child should have to suffer through bipolar depression without options. That's why research like this matters."
What to Expect
From screening to follow-up, we'll support your family every step. Free Uber is provided for every visit.
Screening (Up to 3 Weeks)
We'll review your child's medical history and current symptoms, perform health checks (blood work, ECG, physical exam), and ensure the study is appropriate and safe. If your child is currently taking medications for depression, the study doctor may gradually taper them during this period. Free Uber provided.
Treatment Phase (6 weeks)
Your child takes 1 capsule daily for 6 weeks. The study is double-blind with a 50/50 chance your child receives cariprazine or placebo. You'll bring your child in for regular visits (about weekly) so the study team can monitor symptoms, side effects, and overall health. Uber picks you up and brings you home.
Safety Follow-Up (4 Weeks)
After the treatment phase, we'll continue to check on your child's health and well-being. If your child successfully completes the full 13 weeks, they may be eligible for a separate long-term safety study. Transportation is always included.
Support & Transportation
Our team coordinates every visit and provides compassionate support to both you and your child. Many families find the structure, regular check-ins, and expert psychiatric care helpful. Free round-trip Uber is provided for every visit.
Frequently Asked Questions
Find answers to common questions for parents and guardians considering this pediatric clinical research study.
Have more questions about the study?
Call todayRequest Your Free Evaluation
Find out if your child may be a good fit for this investigational study. Our team will contact you within 24 hours.
Why Request an Evaluation?
Voluntary Participation
Participation is voluntary. This is an investigational study with specific eligibility criteria.
No-Cost Evaluation
Your consultation and all study-related care is provided at no cost to qualified families.
No Obligation
The consultation is informational only - you decide if this investigational study is right for your child.
Call today
Call or text +1 (404) 999-2734. Or email info@denali-health.com. We provide the Uber - you do not need to worry about getting here.
Office Location
Address
5329 Memorial Drive STE A1
Stone Mountain, GA 30038
Hours
Mon–Fri: 8am–5pm
Sat: 9am–1pm (by appt)
Transportation
Free Uber provided
Free parking if preferred
If Your Child Is in Crisis Right Now
If your child is having thoughts of suicide or self-harm, please reach out for help immediately:
- Crisis Lifeline: Call or text 988
- Emergency: Call 911
- Crisis Text Line: Text HOME to 741741
Your child matters. Their life matters. Help is available right now.