NCT00242229已完成不适用
A 6 Month, Open-Label Evaluation of the Long-Term Safety of DVS-233 SR in Elderly Outpatients With Major Depressive Disorder (MDD)
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 52 人开始时间: 2004年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 主要终点
- To evaluate the long-term safety and tolerability of DVS SR in elderly outpatients with MDD.
研究概览
简要总结
To evaluate the overall safety and tolerability profile of two dose levels of DVS-233 SR during 6 months of open-label treatment in elderly outpatients with major depressive disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients men and women aged 65 years or older.
- •Mini Mental State Examination score of 24 or above.
- •Subjects must have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), single or recurrent episode, without psychotic features, on study day 1, if depressive symptoms for at least 30 days prior to screening visit and minimum screening and study day -1 (baseline) scores of 16 on the Hamilton Psychiatric Rating Scale for Depression (HAM-D17).
排除标准
- •Significant risk of suicide based on clinical judgment, including common suicidal thoughts, and suicide being considered as a possible solution, even without specific plans or intention.
- •Current (within 12 months of baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder as assessed by the modified Mini International Neuropsychiatric Interview (MINI). Current (within 12 months of baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder as assessed by the modified MINI and considered by the investigator to be primary, causing a higher degree of distress or impairment than MDD. Presence (within 12 months of baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic). Presence of dementia.
- •Depression associated with the presence of an organic mental disorder due to a general medical condition or a neurologic disorder.
- •Other exclusion applies.
结局指标
主要结局
To evaluate the long-term safety and tolerability of DVS SR in elderly outpatients with MDD.
次要结局
- To evaluate the long-term response of subjects receiving DVS SR for the clinical global evaluation, functionality, general well-being, pain and absence of depressive symptoms (Hamilton Psychiatric Rating Scale for Depression 17-item score < or = 7).
研究者
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