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RecruitingNCT04777357

A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolarity type I.

This study is recruiting. It focuses on bipolarity and currently lists participation information in the United States and Russian Federation.

BipolarityDrugFrom 10 Years to 17 Years
In plain English

Key information made simple

This study is comparing Cariprazine with placebo for people with Depression or Bipolarity I. Participants receive Cariprazine or placebo and complete study visits and assessments. Some participants may receive placebo instead of the study treatment, and direct benefit is not guaranteed.

What to expect

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.

Public study data

Key study information

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
Condition
Depression; Bipolar I Disorder
Study status
Recruiting
Phase
Phase 3
Sponsor / lead affiliation
AbbVie
Intervention
Cariprazine, Placebo
Location / country
United States, Russian Federation
Contact
ABBVIE CALL CENTER, Site Coordinator
Email
abbvieclinicaltrials@abbvie.com, cqthai@health.ucdavis.edu, jemmanuella@nextleveltrials.com, sekeia.willis@sclamanagement.com
Phone
844-663-3742, 916-734-3574, 773-424-2430, 832-969-6157
Registry
ClinicalTrials.gov
Why this study may matter

Why this study may matter

This study may matter because it is evaluating Cariprazine, Placebo in a structured research setting. For people exploring bipolarity research, clear information about the goal, status, contacts, and official source can support better questions before any decision.

Before joining

Questions to ask before joining

Official source

Registry reference

This page links back to the public source record so people can verify details directly with the registry and research team.

If you want the full study description, eligibility criteria, locations, and sponsor information in the original format, this is the place to check before taking the next step.

Open source record
Need help deciding?

Ask HopeStage to review this study with me

This form records your interest so HopeStage can follow up with practical guidance. It is not a medical eligibility decision and it does not guarantee a study spot.

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In practice

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.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

Study clarity

Things to check before joining

Sponsor
AbbVie
Sponsor type
Unknown or unclear
Main activity
medication or study treatment
Intervention
Cariprazine, Placebo
Time commitment
multiple visits or assessments
Study phase
Phase 3
Enrollment
Not available
Recruitment status
Recruiting
Source
Official registry link
FAQ

Questions about this study

What is A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolarity type I.?

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.

Who is behind this study, and what type of sponsor is it?

This study is sponsored by AbbVie. We could not clearly classify the sponsor type from the available data. Check the official source record to verify who is responsible for the study.

What does participation involve, what phase is it, and what should I ask about safety?

This study may involve medication or study treatment, study visits, and assessments. The time commitment is multiple visits or assessments. The study phase is Phase 3. Earlier-phase studies are often more focused on safety, dose, or feasibility, while later-phase studies usually involve more participants and more information about the intervention. The official source record gives the most accurate details. Enrollment is not available in HopeStage data. HopeStage cannot say whether a study is safe or right for you. Before joining, ask the research team about possible risks, time commitment, visits, side effects, compensation, safety monitoring, and whether participation may affect your current care.

Where can I verify the study details?

Use the official source record linked on this page to check the full study description, recruitment status, eligibility criteria, locations, sponsor information, phase, enrollment, contact details, and any listed risks or requirements.

A Study to Assess Change in Disease Activity and. — Bipolarity Clinical Trial | HopeStage