Actively Recruiting
A Multicenter, Prospective Observational Study to Evaluate Treatment Patterns and Safety in Patients With Bipolar Disorder Taking Olanzapine
Led by Boryung Pharmaceutical Co., Ltd · Updated on 2025-12-04
3000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have signed the informed consent after receiving information about the purpose and method of this study.
- Patients diagnosed with bipolar disorder and scheduled to receive olanzapine.
- Patients who understand the contents of the survey and can answer the questions directly.
You will not qualify if you...
- Female patients who are pregnant, have childbearing potential, or are breastfeeding.
- Has received an investigational product within 12 weeks from the study enrollment or has plans to participate in another clinical trial during the participation of this study.
- Other subjects who are considered inappropriate to participate in this study by the judgment of the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 27 months
Participants who undergo routine care with olanzapine are observed to evaluate treatment patterns and safety.
Visits at baseline, 8 weeks, and 12 weeks with additional safety assessments up to 27 months
Trial Site Locations
Total: 1 location
1
CHA Bundang Medical Center
Seongnam, South Korea
Actively Recruiting
Research Team
S
Shinyoung Oh
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here