A Study of Olanzapine in Participants With Bipolar Disorder.
ConditionBipolar Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorBoryung Pharmaceutical Co., Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients with bipolar disorder who require olanzapine administration
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Olanzapine
DrugAs 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.
Treatment groups
No treatment groups listed
Trial outcomes
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
Time frame
Baseline, 8weeks, 12weeksSecondary outcomes
1
Change From Baseline in Young Mania Rating Scale (YMRS) Score at 8 Weeks and 12Weeks.
The YMRS scoring system ranges from 0 (no symptoms) to 4 or 8 (severe symptoms)
Time frame
Baseline, 8weeks, 12weeks2
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at 8 Weeks and 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
Time frame
Baseline, 8weeks, 12weeks3
Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) Score at 8 Weeks and 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).
Time frame
Baseline, 8weeks, 12weeks4
Clinical Global Impression Scale-Improvement (CGI-I) scores at 8 and 12 weeks after drug administration
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).
Time frame
Baseline, 8weeks, 12weeksSponsors and contacts
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Source ClinicalTrials.gov