Phase IV Pilot Study to Examine the Efficacy and Safety of Escitalopram in Doses up to 50 mg for the Treatment of Patients With Major Depressive Disorder (MDD).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The number of patients achieving remission (MADRS<9).
研究概览
简要总结
This will be an open label study of escitalopram. Patients not responsive to citalopram will be switched directly to escitalopram.
Patients will receive escalating doses of escitalopram up to a maximum of 50 mg until they either achieve remission (MADRS <9) or fail to tolerate the dose.
详细描述
Patients will receive escalating doses of escitalopram up to a maximum of 50 mg until they either achieve remission (MADRS <9) or fail to tolerate the dose.
Visit 1 - (Initial visit) - escitalopram 10 mg Visit 2 - (Week 2) - escitalopram 20 mg Visit 3 - (Week 4) - review visit Visit 4 - (Week 6) - MADRS <12 - continue 20 mg MADRS >12 - escitalopram 30 mg Visit 5 - (Week 8) - MADRS <8 - continue current dose MADRS >8 - escalate dose (20 mg to 30 mg or 30 mg to 35mg)
Thereafter, Patients who have achieved remission will be maintained on the remission dosage and reviewed at four weekly intervals. At any subsequent visit where the MADRS is >8 they will have a dosage increase
Patients who have not achieved remission will have dosage escalated by 5 mg at two weekly intervals until remission, a maximum dose of 50 mg is achieved or the dosage is intolerable when they will be reduced to the previous tolerable dose.
Patients will be followed up until eight months from their initial visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •written informed consent will be obtained from each patient
- •aged 18 to 65 inc
- •suffering from MDD as defined by DSM IV
- •have been taking citalopram in a dose of at least 20mg for at least six weeks
- •an inadequate response -- defined as failure to achieve a MADRS score of <12
排除标准
- •Significant other psychiatric disorder which would interfere with trial assessments. Co-morbid generalized anxiety disorder (GAD) and panic will be permitted where MDD is considered the primary diagnosis .
- •history of mania or bipolar disorder
- •Known contraindication for the use of citalopram or escitalopram.
- •Significant bleeding disorder
- •Prominent suicidal ideation (score more than 4 in the MADRS "suicidal thoughts" item)
- •Alcohol or substance dependence in the past 6 months
- •Major physical illness
- •Significant liver or renal function abnormality
- •Significant ECG abnormalities
- •Pregnant or lactating females
- •Inadequate contraception
研究组 & 干预措施
Active
Active escitalopram
干预措施: escitalopram (Drug)
结局指标
主要结局
The number of patients achieving remission (MADRS<9).
时间窗: 8 months
次要结局
未报告次要终点