A Retrospective Observational Study on Weight Change, Effectiveness, and Safety Following Switching to Lurasidone in Korean Patients With Bipolar Disorder Under Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Change in body weight from baseline to 16 weeks
研究概览
简要总结
Study Objective: To evaluate the treatment effectiveness and safety by analyzing prescription patterns in a routine clinical practice setting and observing changes in clinical indicators (weight, BMI, HAM-D, CGI-S, CGI-I) among patients prescribed Lurasidone for the treatment of bipolar disorder.
Study Design: Retrospective, Multi-center, Investigator-Initiated Observational Study.
详细描述
This study is a retrospective, multi-center, observational study. Based on the Institutional Review Board (IRB) approval date, patients will be registered who had been stably taking atypical antipsychotics (Aripiprazole, Olanzapine, Quetiapine) for more than 8 weeks during the past period for the treatment of bipolar disorder, but changed the medication to Lurasidone due to metabolic side effects (weight gain) (patients followed up for 16 weeks). Clinical effectiveness and safety information, such as adverse events, will be collected through body weight and questionnaires (HAM-D, CGI-S, CGI-I) before and after switching Lurasidone.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 65 years
- •Confirmed diagnosis of bipolar disorder
- •Minimum 8-week stable treatment on atypical antipsychotics (Aripiprazole, Olanzapine, Quetiapine) followed by a switch to Lurasidone due to metabolic side effects (weight gain).
- •Completed 16-week follow-up post-switch
排除标准
- •Pregnant or lactating women
- •Subjects for whom administration of lurasidone is contraindicated according to the approved labeling
- •Subjects who discontinued lurasidone or switched to another medication within 8 weeks of the initial switch to lurasidone
- •Subjects for whom data on body weight, height, HAM-D, CGI-S, or CGI-I were not collected at least once across all visits
- •Subjects judged by the investigator to be ineligible for participation in the study for other reasons
研究组 & 干预措施
Bipolar Disorder Patients Switched to Lurasidone
Patients diagnosed with bipolar disorder who had been stably treated with atypical antipsychotics (aripiprazole, olanzapine, or quetiapine) for at least 8 weeks, subsequently switched to lurasidone due to metabolic side effects (weight gain), and completed a 16-week follow-up period post-switch.
干预措施: Lurasidone (Drug)
结局指标
主要结局
Change in body weight from baseline to 16 weeks
时间窗: 16 weeks
Change in body weight from baseline to 16 weeks after Lurasidone prescription in the total population
次要结局
- Mean values and changes in CGI-I scores(4 weeks and 16 weeks)
- Antipsychotic equivalent doses(Before and after medication switch)
- Change in body weight according to Lurasidone dosage(16 weeks)
- Change in body weight in subjects with concomitant use of antipsychotics(16 weeks)
- Change in body weight and rate of weight change(4 weeks and 16 weeks)
- Change in body weight according to prior medication(4 weeks and 16 weeks)
- Change in BMI(4 weeks and 16 weeks)
- Change in HAM-D scores(4 weeks and 16 weeks)
- Change in scores for each HAM-D item(4 weeks and 16 weeks)
- Change in CGI-S scores(4 weeks and 16 weeks)
研究者
Dong-Wook Kim
Director
Garam Mental Health Clinic