NCT00177528已完成4 期
Safety and Efficacy of Venlafaxine XR in Elderly Patients With Major Depression
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- The safety and tolerability of venlafaxine XR.
研究概览
简要总结
This research study is to evaluate the safety and usefulness of venlafaxine-XR in the treatment of major depression in the elderly.
详细描述
The primary objective of this pilot study is to evaluate the safety of venlafaxine extended release formulation (XR) in the treatment of geriatric non-psychotic depression. This pilot study's specific aims are to assess the safety of venlafaxine XR in the geriatric population, to estimate the response rate of older depressed subjects treated under open conditions and to evaluate pharmacokinetic characteristics that may impact on safety and outcome.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women of all races who are 60 years old or older;
- •a DSM-IV diagnosis of major depressive episode without psychotic features;
- •17-item Ham-D score of >15 for potential subjects who have not received any antidepressant treatment during this illness episode or HAM-D > 11 for potential subjects who have received treatment with an antidepressant (other than venlafaxine-XR) during this illness episode;
- •a MMSE score of >15.
排除标准
- •history of meeting DSM-IV criteria for mania, schizophrenia or other psychotic disorder;
- •history of substance abuse or dependence, including alcohol, within the last three months;
- •current hyponatremia (as defined as a serum sodium level < 130 meq/l);
- •untreated or uncontrolled hypertension;
- •a history of being unable to tolerate venlafaxine-XR or venlafaxine immediate release formulation;
- •history of receiving venlafaxine-XR or venlafaxine immediate release formulation of 6 or more weeks at 300mg/d during index depressive episode; (7) EKG revealing QTc > 480 msec;
- •myocardial infarction, unstable angina, palpitation or cardiogenic syncope within 3 months prior to entering this study;
- •the presence of active suicidal ideation with intent.
结局指标
主要结局
The safety and tolerability of venlafaxine XR.
Rate of Major Depression remission to treatment.
次要结局
- Participant characteristics that influence safety and remission rate.
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Study Evaluating Venlafaxine Extended-Release in Depressed and Anxious PatientsAnxiety DisordersDepressionNCT00546923Wyeth is now a wholly owned subsidiary of Pfizer210
已完成
4 期
Effectiveness of Long-Term Versus Short-Term Treatment of Generalized Anxiety Disorder With Venlafaxine XRAnxiety DisordersNCT00183274University of Pennsylvania268
已完成
4 期
Avelox for Treatment of Elderly Patients With Community Acquired PneumoniaPneumoniaNCT00665327Bayer401
已完成
4 期
Study Comparing the Efficacy of Venlafaxine XR Vs. SSRIs and Conventional Antidepressants in Depressed PatientsMajor Depressive DisorderNCT00474708Wyeth is now a wholly owned subsidiary of Pfizer1,151
已完成
2 期
effectiveness of Venlafaxine and Duloxetine on peripheral neuropathy caused by chemotherapypripheral neuropathy.Drug-induced polyneuropathyIRCT2015060922632N1Vice chancellor for research, Kermanshah University of Medical Sciences156