A Study of Olanzapine in Participants With Bipolar Disorder.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Olanzapine.
- Who it may be relevant to
- Registry conditions: Bipolar Disorder. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Prospective Observational Study to Evaluate Treatment Patterns and Safety in Patients With Bipolar Disorder Taking Olanzapine
Overview
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.
Interventions
- Drug Olanzapine
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 outcome measures
- Treatment pattern [Time frame: Baseline, 8weeks, 12weeks]
Secondary outcome measures (5)
- Change From Baseline in Young Mania Rating Scale (YMRS) Score at 8 Weeks and 12Weeks. [Time frame: Baseline, 8weeks, 12weeks]
- Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at 8 Weeks and 12Weeks. [Time frame: 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]
- Clinical Global Impression Scale-Improvement (CGI-I) scores at 8 and 12 weeks after drug administration [Time frame: Baseline, 8weeks, 12weeks]
- Adverse events [Time frame: Up to 27months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- CHA Bundang Medical Center — Seongnam
Identifiers
NCT: NCT07263191 · BR-OLZ-OS-401