Condition: Depression · Bipolar I Disorder · Sponsor: AbbVie
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 follo…
This description comes directly from the study's public registry record.
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| Pillar Clinical Research /ID# 226504 | Bentonville, Arkansas, United States | Completed |
| Advanced Research Center /ID# 227073 | Anaheim, California, United States | Recruiting |
| Care Access Research /ID# 226316 | Beverly Hills, California, United States | Completed |
| Inland Pyschiatric Medical Group - Chino /ID# 278667 | Chino, California, United States | Recruiting |
| ProScience Research Group /ID# 226223 | Culver City, California, United States | Completed |
| National Institute of Clinical Research - Garden Grove /ID# 262835 | Garden Grove, California, United States | Completed |
| Accellacare - Long Beach /ID# 279482 | Long Beach, California, United States | Recruiting |
| Duplicate_Alliance for Research - Long Beach /ID# 226522 | Long Beach, California, United States | Completed |
| CHOC Children's Hospital /ID# 260298 | Orange, California, United States | Recruiting |
| ATP Clinical Research- Orange /ID# 253719 | Orange, California, United States | Completed |
| Prospective Research Innovations Inc /ID# 240774 | Rancho Cucamonga, California, United States | Completed |
| Inland Psychiatric Medical Group /ID# 274621 | Redlands, California, United States | Recruiting |
+ 69 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04777357