Abbvie ((ABBV)), Abbvie (($CC:ABBV.CUR)) announced an update on their ongoing clinical study.
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AbbVie’s latest clinical 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, aims to evaluate the efficacy and safety of Cariprazine in treating depressive episodes in pediatric patients with bipolar I disorder. This study is significant as it addresses the limited pharmacotherapeutic options available for this demographic, potentially offering a new treatment avenue.
The intervention being tested is Cariprazine, an oral capsule drug already approved for adult bipolar I disorder depressive episodes. Participants will receive either Cariprazine or a placebo over a six-week period, with dose adjustments based on age, weight, and response to treatment.
The study is designed as a Phase 3, randomized, double-blind, parallel-group trial with triple masking involving participants, investigators, and outcomes assessors. The primary purpose is to assess treatment efficacy and safety.
Key dates for the study include an actual start date of April 28, 2021, with the latest update submitted on July 14, 2025. These dates are crucial for tracking the study’s progress and anticipated completion.
This study update could positively impact AbbVie’s stock performance and investor sentiment by potentially expanding Cariprazine’s market to include pediatric patients. The study’s progress is also relevant in the context of limited competition in this specific treatment area.
The study is ongoing, with further details available on the ClinicalTrials portal.