The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q)
研究概览
简要总结
The purpose of this is to determine the efficacy, safety, and tolerability of sertraline in patients with major depressive disorder (MDD) who have shown inadequate response ot escitalopram.
详细描述
Eight week open-label flexible dose trial in adult outpatients diagnosed with Major Depressive Disorder (MDD) who have had a prior failure with escitalopram. Failure is operationally defined as either premature discontinuation because of side effects or the report of an incomplete response to escitalopram, minimum dose 10mg/day, maintain for 3 weeks or more. 10mg/day was chosen because 1) it is the most commonly prescribed single dose of escitalopram in clinical practice, 2) it is equivalent to approx. 30mg/day of arcemic citalopram and 3) escitalopram has very high potency at the serotonin transporter (Ki=1.1); this means that escitalopram would be expected to saturate the transporter at relatively low doses. A total of twenty patients will be treated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary DSM-IV diagnosis of Major Depressive episode of MDD without psychotic symptoms. Additional axis I diagnoses will be permitted only if they are identified as secondary diagnoses
- •Ham-D 21 item score of greater than or equal to 18
- •Age 18 and above
- •Ability and willingness to provide consent for participation
- •Failure to respond to escitalopram
排除标准
- •Diagnosis of Bipolar Disorder or any psychotic disorder
- •Alcohol or drug abuse or dependence currently or in the last 6 months
- •A history of non-response or intolerance to sertraline at least 50 mg. for at least 4 weeks or more
- •Concomitant use of another antidepressant or use of an antidepressant within 2 weeks of baseline (4 weeks for fluoxetine)
- •Use within 1 week of baseline, or concomitant use of any psychotropics with the exception of zolpidem for sleep
- •Use within 4 weeks of baseline or concomitant use of benzodiazepines with the exception of PRN use of diazepam 10 mg/day or its equivalent
- •Presence of serious and/or unstable medical condition
- •Score of 3 or 4 on the suicide item (item 3) of the Ham-D scale
- •Known sensitivity of sertraline
结局指标
主要结局
Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q)
Hamilton Rating Scale for Depression (21-item) total score
Clinical Global Impressions - Improvement Scale
次要结局
- Clinical Global Impressions - Severity Scale
- Hamilton Anxiety Scale Total score
研究者
Richard C. Shelton
Director of Mood Disorders Clinic
Vanderbilt University