Actively Recruiting
Observational Study on Treatment Patterns and Safety of Olanzapine in Adults With Bipolar Disorder
Led by Boryung Pharmaceutical Co., Ltd · Updated on 2025-12-04
3000
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying treatment patterns and safety in patients with bipolar disorder who are taking olanzapine. The study aims to understand how different demographic and clinical characteristics affect treatment, and to evaluate whether education about weight gain can help prevent this side effect of olanzapine. This is a multicenter, prospective observational study sponsored by Boryung Pharmaceutical Co., Ltd. The study involves patients who are prescribed olanzapine as part of their regular clinical care. Since this is an observational study, medication choices, dosages, and treatment durations are decided by the patients clinicians based on usual practice. Participants will be observed over time without altering their prescribed treatment. The study includes follow-up assessments at baseline, 8 weeks, and 12 weeks, with some safety monitoring continuing up to 27 months. Participants will be asked to complete surveys and rating scales that measure mood symptoms and clinical impressions at several visits. Researchers will track treatment patterns, changes in mania and depression scores, and clinical global impressions to evaluate effectiveness and safety. Adverse events will be monitored for up to 27 months. The total involvement duration varies, with key assessments at the start and during the 12-week observation period.
CONDITIONS
Brief Title
A Study of Olanzapine in Participants With Bipolar Disorder.
Research Team
S
Shinyoung Oh
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