Abbvie ((ABBV)) announced an update on their ongoing clinical study.
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AbbVie is conducting a study titled 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. The study aims to evaluate the change in disease state and safety of cariprazine in treating depressive episodes in pediatric patients with bipolar I disorder, addressing a gap in treatment options for this age group.
The intervention being tested is Cariprazine, an oral capsule already approved for adult patients with bipolar I disorder. The study involves two groups: one receiving Cariprazine and the other a placebo, to assess its efficacy and safety in children and adolescents.
This is an interventional study with a randomized, parallel assignment model. It employs triple masking to ensure unbiased results, with the primary purpose of treatment. Participants are randomly assigned to either the Cariprazine or placebo group.
The study began on February 26, 2021, with the latest update submitted on August 26, 2025. These dates are crucial as they indicate the study’s progression and the most recent data available.
The outcome of this study could significantly impact AbbVie’s stock performance and investor sentiment, as successful results may lead to expanded use of Cariprazine in a new demographic. This could position AbbVie favorably against competitors in the pediatric bipolar disorder treatment market.
The study is ongoing, with further details available on the ClinicalTrials portal.