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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, 8weeks, 12weeks |
| Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at 8 Weeks and 12Weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with bipolar disorder who require olanzapine administration
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shinyoung Oh | Contact | +82 2-708-8000 | syoh@boryung.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center | Recruiting | Seongnam | South Korea |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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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 |
| Baseline, 8weeks, 12weeks |
| 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). | Baseline, 8weeks, 12weeks |
| 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). | Baseline, 8weeks, 12weeks |
| Adverse events | Up to 27months |
| D006571 | Heterocyclic Compounds |