Olanzapine for people with bipolar disorder
A Multicenter, Prospective Observational Study to Evaluate Treatment Patterns and Safety in Patients With Bipolar Disorder Taking Olanzapine
This project tests how people with bipolar disorder use olanzapine and whether teaching them about weight gain helps prevent it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 1 site (Seongnam) |
| Trial ID | NCT07263191 on ClinicalTrials.gov |
What this trial studies
This is an observational study following people with bipolar disorder who are scheduled to start olanzapine to characterize real-world treatment patterns and outcomes. Participants will provide informed consent, complete surveys, and receive education about olanzapine-associated weight gain while investigators collect clinical and demographic data. The study will compare weight and related outcomes over time between those who receive the educational information and baseline measures. Data will be analyzed to identify factors associated with treatment choices and the effectiveness of the educational approach in preventing weight gain.
Who should consider this trial
Good fit: Adults diagnosed with bipolar disorder who can consent, answer study questionnaires, and are scheduled to receive olanzapine are the intended participants.
Not a fit: People who are pregnant, breastfeeding, not taking olanzapine, or unable to complete the surveys are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the findings could help clinicians reduce olanzapine-related weight gain and improve medication tolerability and adherence.
How similar studies have performed: Previous research has consistently shown olanzapine causes weight gain, and behavioral or educational interventions have shown mixed but sometimes positive effects on limiting weight gain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Seongnam
- CHA Bundang Medical Center — Seongnam, South Korea (Recruiting)
Study contacts
- Study coordinator: Shinyoung Oh
- Email: syoh@boryung.co.kr
- Phone: +82 2-708-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.