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Study ID: NCT04777357. We help you review the study, but cannot decide medical eligibility.
RecruitingNCT04777357
Cariprazine for depression
This study is recruiting in the United States and in Russian Federation. It is testing cariprazine for depression.
Bipolarity, DepressionDrugFrom 10 Years to 17 Years
Key information made simple
What is this study testing?
This study is testing whether the Efficacy and Safety of Cariprazine may be useful for adolescents experiencing bipolarity.
What would participation involve?
Participants may receive the Efficacy and Safety of Cariprazine, complete questionnaires or follow-up assessments, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in United States, Russian Federation.
Who is it mainly for?
This study appears to be mainly for adolescents with bipolarity. Because it involves minors, a parent or guardian may need to be involved.
What should you check before joining?
Ask about the dose, safety monitoring, and possible side effects, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, what role parents or guardians have in the process.
Your next step
The official record suggests in-person participation through a hospital, with sites including Pillar Clinical Research /ID# 226504 in Bentonville, Advanced Research Center /ID# 227073 in Anaheim, and Care Access Research /ID# 226316 in Beverly Hills. Participation appears to involve questionnaires, interviews, or regular check-ins about day-to-day experience. The main fit is usually matching the main diagnosis and meeting the main study requirements, while common reasons not to take part include active substance or alcohol problems that could affect the results. This is a later-stage study, which usually means a larger group and a closer look at how well the approach holds up.
Questions to ask before joining
- What are the exact eligibility criteria, and what could exclude someone?
- How many visits, assessments, or follow-ups are expected, and over what period?
- What risks, side effects, practical burdens, or alternatives should be understood first?
- Who should be contacted to confirm locations, timing, compensation, and next steps?
Things to check before joining
Study start dateStarted: April 28, 2021
- Recruitment status
- Recruiting
- Estimated enrollment
- Not clearly listed
- Sponsor
- AbbVie
- Sponsor type
- Unknown or unclear
- Study type
- Drug
- Intervention type
- Medication / drug
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
- Locations
- United States, Russian Federation
- Age range
- From 10 Years to 17 Years
- Official registry ID
- NCT04777357
- Official title
- A 6-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Cariprazine in Pediatric Subjects (10 to 17 Years of Age) in the Treatment of Depressive Episodes Associated With Bipolar I Disorder
- Official source
- Official registry link
Want help reviewing this study?
Study ID: NCT04777357. We help you review the study, but cannot decide medical eligibility.
For you
Taking part may give access to a new approach being evaluated.
It requires regular visits and structured follow-up.
Requires travel, with in-person participation in United States.
Not medical advice
Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com
Questions about this study
What is this study trying to understand?
This study is exploring medication or study treatment for people with bipolarity. Participants may complete study visits, assessments, or follow-up activities defined by the research team. It includes a comparison with placebo. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.
Does this study involve a medication?
This appears to be a medication / drug study involving Cariprazine, Placebo. Phase 3 studies are usually larger and aim to confirm effectiveness and safety in a broader group.
Do I need to want to stop or reduce tobacco use to participate?
The public registry appears to mention tobacco, nicotine, alcohol, cannabis, or another addiction-related topic. Ask the study team whether you need to want to stop, reduce, already be abstinent, or simply meet use-related criteria. Eligibility must be confirmed by the study team.
What would I likely need to do?
You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.
What side effects, interactions, or treatment changes should I check?
If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.
Will I need to travel or attend in-person visits?
The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.
Who is behind this study?
This study is sponsored by AbbVie, which appears to be unknown or unclear. The listed contact or investigator is AbbVie, affiliated with AbbVie. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.
Can I still join this study?
The registry indicates that this study is currently recruiting. This does not mean you are eligible: the study team must confirm the criteria, available locations, and next steps.
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