NCT07263191|Recruiting
A Study of Olanzapine in Participants With Bipolar Disorder.
A Multicenter, Prospective Observational Study to Evaluate Treatment Patterns and Safety in Patients With Bipolar Disorder Taking Olanzapine
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A Multicenter, Prospective Observational Study to Evaluate Treatment Patterns and Safety in Patients With Bipolar Disorder Taking Olanzapine
Sponsor study identifier
observational
3,000
1 country
1
Study Start
October 30, 2025
Actual (reported)Primary Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 30, 2025
Actual (reported)November 23, 2025
Actual (reported)December 4, 2025
Actual (reported)September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with bipolar disorder who require olanzapine administration
CHA Bundang Medical Center
Seongnam, South Korea
First Submitted
November 23, 2025
First Posted
December 4, 2025
Study Start
October 30, 2025
Actual (reported)Primary Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Olanzapine vs. Comparator and Placebo in the Treatment of Patients With Bipolar I Disorder
Contact the study team to confirm eligibility.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 4, 2025
Record last verified: 2025-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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