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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 evaluates the safety and effectiveness of Cariprazine for people with bipolarity.

Medication studyAges 10–17United States + Russia
The study in practice

Understand this study

What is this study about?

This study evaluates the safety and effectiveness of Cariprazine for people with bipolarity.

Who could participate?

This study is for people with type I bipolarity. Listed age limits: 10 years to 17 years. Other eligibility criteria apply.

Listed locations
Bentonville, United States · Anaheim, United States and 65 more locationsSee all locations and recruitment
Activities
Medication described in the protocol · Placebo comparator
Compensation
Payment and expense reimbursement have not been verified.

Registry last updated: · Record retrieved: . These dates do not confirm site availability.

What to know before participating

A point to clarify

This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?

Study clarity

Things to check before joining

Study start dateStarted: April 28, 2021
Recruitment status
Recruiting
Enrollment listed in the registry
380
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, Russia
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

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Recruitment & locations

Recruiting

Bentonville, United States · Anaheim, United States · Beverly Hills, United States

64 more locations
  • Chino, United States
  • Culver City, United States
  • Garden Grove, United States
  • Long Beach, United States
  • Orange, United States
  • Rancho Cucamonga, United States
  • Redlands, United States
  • Sacramento, United States
  • San Diego, United States
  • San Jose, United States
  • Upland, United States
  • West Covina, United States
  • Doral, United States
  • Homestead, United States
  • Miami, United States
  • Miami Springs, United States
  • Orange City, United States
  • Orlando, United States
  • Pensacola, United States
  • Tamarac, United States
  • Tampa, United States
  • Atlanta, United States
  • Decatur, United States
  • Dunwoody, United States
  • Stockbridge, United States
  • Stone Mountain, United States
  • Chicago, United States
  • Naperville, United States
  • Orland Park, United States
  • Indianapolis, United States
  • Shreveport, United States
  • Baltimore, United States
  • Irvington, United States
  • Mount Arlington, United States
  • Buffalo, United States
  • Kinston, United States
  • Avon Lake, United States
  • Cincinnati, United States
  • Cleveland, United States
  • West Chester, United States
  • Oklahoma City, United States
  • Austin, United States
  • Beaumont, United States
  • Bellaire, United States
  • Coppell, United States
  • Dallas, United States
  • Friendswood, United States
  • Houston, United States
  • Mansfield, United States
  • Plano, United States
  • Richmond, United States
  • The Woodlands, United States
  • Bountiful, United States
  • Everett, United States
  • Caguas, Puerto Rico
  • San Juan, Puerto Rico
  • Krasnodar, Russia
  • Moscow, Russia
  • Orenburg, Russia
  • Stavropol, Russia
  • Nizhny Novgorod, Russia
  • Saint Petersburg, Russia
  • Saratov, Russia
  • Russia
Checked Official study record (opens in a new tab)

A listed location does not confirm current availability.

FAQ

Questions about this study

What is this study about?

This study evaluates the safety and effectiveness of Cariprazine for people with bipolarity.

Who is behind this study?

The study sponsor is AbbVie.

Does this study involve medication?

Yes. The study involves medication, including Cariprazine and Placebo.

Who can participate?

This study is for people with type I bipolarity. Listed age limits: 10 years to 17 years. Other eligibility criteria apply.

Is this study still recruiting?

The registry lists this study as recruiting.

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