Bipolar Disorder
Conditions
Keywords
Olanzapine, Observation study, Bipolar Disorder
Brief summary
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
DRUGOlanzapine
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.
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment pattern | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Young Mania Rating Scale (YMRS) Score at 8 Weeks and 12Weeks. | Baseline, 8weeks, 12weeks | The YMRS scoring system ranges from 0 (no symptoms) to 4 or 8 (severe symptoms) |
| Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at 8 Weeks and 12Weeks. | 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 |
| Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) Score at 8 Weeks and 12Weeks. | 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). |
| Clinical Global Impression Scale-Improvement (CGI-I) scores at 8 and 12 weeks after drug administration | 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). |
| Adverse events | Up to 27months | — |
Countries
South Korea
Contacts
Primary ContactShinyoung Oh
Outcome results
None listed