A Study of Olanzapine in Participants With Bipolar Disorder.

November 23, 2025 updated by: Boryung Pharmaceutical Co., Ltd

A Multicenter, Prospective Observational Study to Evaluate Treatment Patterns and Safety in Patients With Bipolar Disorder Taking Olanzapine

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seongnam, South Korea
        • Recruiting
        • CHA Bundang Medical Center
        • Contact:
          • Sang-Hyuk Lee, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with bipolar disorder who require olanzapine administration

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment pattern
Time Frame: Baseline, 8weeks, 12weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Young Mania Rating Scale (YMRS) Score at 8 Weeks and 12Weeks.
Time Frame: Baseline, 8weeks, 12weeks
The YMRS scoring system ranges from 0 (no symptoms) to 4 or 8 (severe symptoms)
Baseline, 8weeks, 12weeks
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at 8 Weeks and 12Weeks.
Time Frame: Baseline, 8weeks, 12weeks
The PHQ-9 scoring system ranges from 0 to 27, with higher scores indicating more severe depression. Each item is scored on a scale from 0 to 3
Baseline, 8weeks, 12weeks
Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) Score at 8 Weeks and 12Weeks.
Time Frame: Baseline, 8weeks, 12weeks
The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 0 (not assessed) through to 7 (amongst the most severely ill patients).
Baseline, 8weeks, 12weeks
Clinical Global Impression Scale-Improvement (CGI-I) scores at 8 and 12 weeks after drug administration
Time Frame: Baseline, 8weeks, 12weeks
The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 0 (not assessed) through to 7 (amongst the most severely ill patients).
Baseline, 8weeks, 12weeks
Adverse events
Time Frame: Up to 27months
Up to 27months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boryung Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

November 23, 2025

First Submitted That Met QC Criteria

November 23, 2025

First Posted (Estimated)

December 4, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 23, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-OLZ-OS-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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