NCT07263191招募中不适用
A Multicenter, Prospective Observational Study to Evaluate Treatment Patterns and Safety in Patients With Bipolar Disorder Taking Olanzapine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Treatment pattern
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Treatment pattern
时间窗: 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
次要结局
- 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)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Pomalidomide Plus Orelabrutinib and Zuberitamab in Untreated Mantle Cell LymphomaNCT07257510Peking University Third Hospital34
招募中
3 期
Functional Constipation: Linaclotide versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, with Functional Constipation (FC)Functional Constipation2022-501946-31-00Abbvie Deutschland GmbH & Co. KG14
招募中
2 期
Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell LymphomaMantle Cell LymphomaNCT07261163Institute of Hematology & Blood Diseases Hospital, China37
招募中
4 期
Aflibercept 8mg for high-frequent Faricimab and prior Aflibercept 2mg treated Neovascular age-related macular degeneration: a monocenter, single-arm, open-label extension study (A-FAN)2024-515497-26-00Medical University Of Graz33
招募中
不适用
A Study of Second- and Later-line Palliative Chemotherapy in Patients With Metastatic Colorectal Cancer.NCT07263178Boryung Pharmaceutical Co., Ltd1,000