NCT01145313已完成不适用
Impact of Atypical Antipsychotic Therapy on Health Outcomes and Costs Among Patients With Major Depressive Disorder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 501
- 主要终点
- Pre/post-augmentation healthcare costs and resource utilization among patients diagnosed with MDD who augment antidepressant therapy with an atypical antipsychotic.
研究概览
简要总结
The primary objective is to examine changes in pre/post-augmentation healthcare costs and resource utilization in patients diagnosed with major depressive disorder (MDD) who augment their current antidepressant therapy with an atypical antipsychotic.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the following criteria will be included in the study:
- •aged 18 to 64 years
- •diagnosis of major depressive disorder during the study timeframe (ICD 9 codes 296.2, 296.3, 311)
- •evidence of at least 6 consecutive claims for traditional antidepressant therapy with a 30 day supply or at least 2 claims with a 90 day supply (consecutive defined as ≤15 days gap)
- •must be continually enrolled during the study timeframe and have both medical and pharmacy benefits
- •evidence of at least 4 consecutive claims for an atypical antipsychotic prescription with a 30 day supply or 2 claims with a 90 day supply (consecutive defined as ≤15 days gap)
- •evidence of antidepressant therapy for at least 60 consecutive days prior to the initiation of atypical antipsychotic
- •After at least a 60 day trial of traditional antidepressant medications, patient augments with an atypical antipsychotic medication for at least 4 months.
排除标准
- •Patients are excluded if they:
- •have any claims for a diagnosis of schizophrenia, schizoaffective or bipolar disorder during the study period
- •have Electroconvulsive therapy (ECT) during the study period
- •new augmentation with mood stabilizers, L-thyroxine (T4), L-Thyronine (T3), buspirone, stimulant, or others during the post-period (table 1)
- •are pregnant during the study period
- •patients with Medicare or Medicaid
结局指标
主要结局
Pre/post-augmentation healthcare costs and resource utilization among patients diagnosed with MDD who augment antidepressant therapy with an atypical antipsychotic.
时间窗: 3 months post-augmentation.
次要结局
- A secondary post-hoc analysis may be conducted to determine differences in outcomes among patients during a longer treatment period, ie 6 month pre- and 6 month post-augmentation.(6 month post-augmentation)
研究者
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