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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04578756
The ClinicalTrials.gov registry entry for NCT04578756 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 310 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (42% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Related
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