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NCT04578756 · ClinicalTrials.gov registry record · Phase 3
Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder
A Phase 3 study of Schizophrenia and Bipolar I Disorder, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 310
- Enrollment target
- 20
- Study locations
NCT04578756: Completed Phase 3 study of Schizophrenia and Bipolar I Disorder, sponsored by AbbVie.
NCT04578756 is a Phase 3 study of Schizophrenia and Bipolar I Disorder that has completed, run by AbbVie. The registered enrollment target is 310 participants, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (42% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04578756, a Phase 3 study of Schizophrenia and Bipolar I Disorder, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 310 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the long-term safety and tolerability of cariprazine in the treatment of pediatric participants with schizophrenia, bipolar I disorder, or autism spectrum disorder (ASD) and to establish the benefit-risk profile of long-term treatment in this population.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receivi
Conditions Studied
Interventions
- DRUG Cariprazine Flexible Dose
Study Locations (20)
Florida
- D&H Doral Research Center-Doral /ID# 255459 - Doral
- Sarkis Clinical Trials /ID# 236893 - Gainesville
- Galiz Research- Palmetto Medical Plaza /ID# 236277 - Hialeah
- Advanced Research Institute of Miami /ID# 242505 - Homestead
- Duplicate_Sandhill Research LLC /ID# 251239 - Lake Mary
- Columbus Clinical Services, Llc /Id# 234281 - Miami
- G+C Research Group, LLC /ID# 261398 - Miami
- Florida Research Center, Inc. /ID# 236515 - Miami
- Links Clinical Trials /ID# 240975 - Miami
- South Florida Research Ph I-IV /ID# 237453 - Miami Springs
- K2 Medical Research - Orlando - South Orlando Avenue /ID# 257528 - Orlando
California
- Advanced Research Center /ID# 241903 - Anaheim
- Duplicate_Alliance for Research - Long Beach /ID# 236261 - Long Beach
- CHOC Children's Hospital /ID# 251019 - Orange
- ATP Clinical Research- Orange /ID# 257095 - Orange
- Prospective Research Innovations Inc /ID# 236098 - Rancho Cucamonga
- University of California, San Diego Department of Psychiatry /ID# 236466 - San Diego
- Pacific Clinical Research Management Group /ID# 234377 - Upland
Alabama
- Harmonex Neuroscience Research /ID# 234938 - Dothan
Arkansas
- Pillar Clinical Research /ID# 236434 - Bentonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2025-10-06 |
| Phase | Phase 3 |
What the finished NCT04578756 record still lists
NCT04578756 is an interventional study that assigns participants to a tested intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (42% higher).
The record links to 3 conditions, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Cariprazine Flexible Dose is the first listed.
NCT04578756 names 20 study sites across 4 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT04578756 about?
NCT04578756 is a clinical study titled "Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder". The purpose of this study is to evaluate the long-term safety and tolerability of cariprazine in the treatment of pediatric participants with schizophrenia, bipolar I disorder, or autism spectrum disorder (ASD) and to establish the benefit-risk profile of long-term treatment in this population.
What is the current status of trial NCT04578756?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 310 participants. The study started on 2021-02-01. Estimated completion is 2025-10-06.
What conditions does trial NCT04578756 study?
This clinical trial studies the following conditions: Schizophrenia, Bipolar I Disorder, Autism Spectrum Disorder (ASD).
What interventions are being tested in trial NCT04578756?
The interventions under investigation include: Cariprazine Flexible Dose (DRUG).
Who is sponsoring clinical trial NCT04578756?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04578756 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04578756's enrollment target sits among peer trials
310 56th of 315 higher than 260 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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