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NCT Number: NCT07263191

A Study of Olanzapine in Participants With Bipolar Disorder.

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHA Bundang Medical Center

Seongnam, South Korea

Location status: Recruiting

Location contact

Sang-Hyuk Lee, M.D., Ph.D.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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).

  4. 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).

  5. Adverse events

    Time frame: Up to 27months

Study contacts

Contact information is provided by the study sponsor or research team.

Shinyoung Oh

CONTACT

[email protected]

+82 2-708-8000

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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