A Study of Olanzapine in Participants With Bipolar Disorder.

NCT07263191 | Recruiting

• 1 other identifier: BR-OLZ-OS-401
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to identify treatment patterns in patients with bipolar disorder receiving olanzapine according to demographic and clinical characteristics and to evaluate the effectiveness of education on weight gain, a side effect of olanzapine, in preventing weight gain.

Conditions

Bipolar Disorder

Keywords

Olanzapine; Observation study; Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Treatment pattern

  Frequency and percentage of the therapeutic class of bipolar disorder agents administered within 8 weeks prior to baseline will be presented based on the patients' demographic factors and clinical characteristics. Furthermore, frequency and percentage of the therapeutic class patterns of bipolar disorder agents administered after baseline will be presented

  Baseline, 8weeks, 12weeks

Secondary Outcomes (5)

• Change From Baseline in Young Mania Rating Scale (YMRS) Score at 8 Weeks and 12Weeks.

  Baseline, 8weeks, 12weeks

• Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at 8 Weeks and 12Weeks.

  Baseline, 8weeks, 12weeks

• Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) Score at 8 Weeks and 12Weeks.

  Baseline, 8weeks, 12weeks

• Clinical Global Impression Scale-Improvement (CGI-I) scores at 8 and 12 weeks after drug administration

  Baseline, 8weeks, 12weeks

• Adverse events

  Up to 27months

Interventions

Olanzapine DRUG

As this is a non-interventional study designed to collect data as part of routine clinical practice, the selection and dosage of medication, treatment period, and whether or not to change it are all based on the clinician's judgment.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with bipolar disorder who require olanzapine administration

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

CHA Bundang Medical Center

Seongnam, South Korea

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Shinyoung Oh

CONTACT

+82 2-708-8000; syoh@boryung.co.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)