Cariprazine Real-world Use in Bipolar I Disorder: Effectiveness, Functioning, Quality of Life, and Tolerability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 28
- 主要终点
- Change From Baseline on Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
Bipolar I disorder (BP-I) is a common, chronic, and disabling mental illness with significant morbidity and mortality defined by episodes of mania and depression (or symptoms of both at once, known as mixed features). This prospective, observational study will examine effectiveness, functioning and quality of life outcomes in adult patients with BP-I experiencing a major depressive episode (with or without mixed features) requiring treatment and initiating treatment with cariprazine. It will examine outcomes of cariprazine treatment in a real-world setting in patients with BP-I commonly seen in clinical practices.
Cariprazine (Vraylar) is a medication indicated in the United States and Canada to treat adult patients experiencing manic, mixed or depressive episodes associated with BP-I. This study plans to enroll approximately 170 adult patients with BP-I from the United States and Canada. Cariprazine should be prescribed by the physician under the usual and customary practice of physician prescription. The decision to initiate treatment with cariprazine should be made prior to, and independently from, the patient's decision to participate in the study.
Participants will receive cariprazine as prescribed by their physician. Observational data will be collected during visits which should align to routine standard of care for a duration of up to 24 weeks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a physician-confirmed diagnosis of BP-I, with or without comorbidities.
- •Prescribed cariprazine as part of routine clinical practice with the intention of treating as per the approved market label, respective country indications, and by the physician under usual and customary practice of physician prescription.
- •Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score >= 20 at baseline.
- •Have a Functioning Assessment Short Test (FAST) score >= 21 at baseline.
- •Naïve to cariprazine in the current major depressive episode.
排除标准
- •Have a medical or psychiatric condition, or planned surgical procedure, which will interfere with study participation, as judged by the investigator.
- •Have a known contraindication to cariprazine including any of the following:
- •Hypersensitivity to cariprazine or any ingredient in the formulation
- •For all sites, concomitant use of strong cytochrome P450 (CYP) 3A4 inhibitors and inducers
- •For Canadian sites, as per country label, concomitant use of moderate CYP 3A4 inhibitors and inducers
- •Current major depressive episode duration > 12 months.
研究组 & 干预措施
Cariprazine
Participants will receive cariprazine as prescribed by their physician in routine clinical practice. The decision to initiate cariprazine should be made prior to, and independently from, the decision to participate in this study.
结局指标
主要结局
Change From Baseline on Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
时间窗: Up to Week 12
MADRS is a 10-item questionnaire that is rated by investigators to assess changes in depression symptoms over the past week. The individual items (apparent sadness, reported sadness, feelings of tension, reduced appetite, reduced sleep, lassitude, concentration difficulties, pessimistic thoughts, inability to feel emotions, and suicidal thoughts) are scored from 0 (no symptoms) to 6 (maximum severity) and summed for the total score (range 0 to 60). Higher scores indicate more severe depression.
次要结局
- Change From Baseline on Functioning Assessment Short Test (FAST) Total Score(Up to Week 12)