NCT00691353已完成不适用
Subjective Well Being of Patients Receiving Atypical Antipsychotics as Monotherapy or Cotherapy With Mood Stabilizers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Difference in the scores reported in YMRS and Hamilton - D scales from baseline(start of therapy)
研究概览
简要总结
Cross - Sectional study requiring one visit at the investigators office for the data collection.
- Target Group: Patients that suffer from Bipolar Disorder Type 1.
- YMRS - HAMILTON and GAF scales are going to be used to assess the clinical outcome. The findings are going to be based on the different scores reported by Specialists (before the patients started to use as a therapy atypical antipsychotics / at the time that the visit actually takes place for the cause of the study.) We predefine the time period that the patient should be using atypical antipsychotics at minimum (2 months).
- The first 9 consecutive patients that visit the Specialist and meet the entry criteria and signs the ICF will be recruited in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Patients that are diagnosed with Bipolar Disorder Type 1 according to diagnostic criteria DSM - IV
- •Patients that have started therapy with atypical antipsychotics as monotherapy or cotherapy with mood stabilizers the last three months, but have completed 2 full months of therapy.
- •Patients with anxiety disorder can be recruited in the study unless it is dominant.
排除标准
- •Patients that use antidepressant medication
- •Patients who were treated with depot antipsychotic in the last quarter before their enrollment in the study.
- •Patients who are addicts of toxic substances.
- •Patients who suffer from other serious diseases.
结局指标
主要结局
Difference in the scores reported in YMRS and Hamilton - D scales from baseline(start of therapy)
时间窗: Assessment of the progress of disease 2 to 4 months after the initiation of the therapy(baseline)
Assessment of functioning - Relative score reported in GAF scale
时间窗: 2 - 4 months after the initiation of the therapy. No baseline comparison
次要结局
- To depict sociodemographic characteristics and comorbidities.(Reported at the site visit)
研究者
研究点 (1)
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