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NCT04777357 · ClinicalTrials.gov registry record · Phase 3
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 Bipolar I Disorder.
A Phase 3 study of Depression and Bipolar I Disorder, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 380
- Enrollment target
- 20
- Study locations
NCT04777357 is a Phase 3 study of Depression and Bipolar I Disorder that is actively recruiting participants, run by AbbVie. The registered enrollment target is 380 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (52% lower). The trial reports 20 study locations across 3 states.
The verdict
NCT04777357, a Phase 3 study of Depression and Bipolar I Disorder, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 380 participants
- Enrollment target
- 20
- Study locations
Study Summary
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults, therefore pharmacotherapeutic options are limited. Given the change in disease state and safety demonstrated in adults with depressive episodes associated with bipolar I disorder, the purpose of this study is to evaluate the change in disease state and safety of cariprazine in the treatment of depressive episodes associated with bipolar I disorder in the pediatric population. Cariprazine is an approved drug for the treatment of depressive episodes in adult participants with bipolar I disorder. Study doctors put participants in 1 of 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 380 Participants ages 10-17 years with bipolar I disorder will be enrolled in approximately 60 sites worldwide. Participants receiving the study drug will receive Dose A or B of Cariprazine based on age and weight. At Week 3, participants with insufficient response will have their dose increased to Dose B or Dose C, while participants with sufficient response will continue receiving the Dose A or B for the remainder of the treatment period. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cariprazine
Study Locations (20)
California
- Advanced Research Center /ID# 227073 - Anaheim
- Care Access Research /ID# 226316 - Beverly Hills
- Inland Pyschiatric Medical Group - Chino /ID# 278667 - Chino
- ProScience Research Group /ID# 226223 - Culver City
- National Institute of Clinical Research - Garden Grove /ID# 262835 - Garden Grove
- Duplicate_Alliance for Research - Long Beach /ID# 226522 - Long Beach
- CHOC Children's Hospital /ID# 260298 - Orange
- ATP Clinical Research- Orange /ID# 253719 - Orange
- Prospective Research Innovations Inc /ID# 240774 - Rancho Cucamonga
- Inland Psychiatric Medical Group /ID# 274621 - Redlands
- University of California Davis Health /ID# 268306 - Sacramento
- University of California, San Diego Department of Psychiatry /ID# 226463 - San Diego
- Lumos Clinical Research Center /ID# 262805 - San Jose
- Pacific Clinical Research Management Group /ID# 227075 - Upland
Florida
- D&H Doral Research Center-Doral /ID# 255458 - Doral
- Advanced Research Institute of Miami /ID# 228222 - Homestead
- Columbus Clinical Services, Llc /Id# 229792 - Miami
- G+C Research Group, LLC /ID# 261399 - Miami
- Florida Research Center, Inc. /ID# 240775 - Miami
Arkansas
- Pillar Clinical Research /ID# 226504 - Bentonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 380 participants |
| Start Date | 2021-04-28 |
| Est. Completion | 2027-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04777357
The ClinicalTrials.gov registry entry for NCT04777357 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 380 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (52% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04777357 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04777357 about?
NCT04777357 is a clinical study titled "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 Bipolar I Disorder.". Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depr...
What is the current status of trial NCT04777357?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 380 participants. The study started on 2021-04-28. Estimated completion is 2027-03.
What conditions does trial NCT04777357 study?
This clinical trial studies the following conditions: Depression, Bipolar I Disorder.
What interventions are being tested in trial NCT04777357?
The interventions under investigation include: Placebo (DRUG), Cariprazine (DRUG).
Who is sponsoring clinical trial NCT04777357?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04777357 being conducted?
This trial has 20 study locations across Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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