Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- 16-Item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16)
研究概览
简要总结
This study was initially designed to test the efficacy of Venlafaxine HCl in reducing incidence of the onset of major depression after a new spinal cord injury (SCI). After several protocol modifications, the purpose of the study is to test the effectiveness of a sub-therapeutic dose of Venlafaxine HCl to reduce mild to moderate symptoms in persons with SCI.
详细描述
The successes of psychological and pharmacological modes of intervention in treating depression, both alone and combined, are well documented in the literature. While a great deal of research has identified specific clinical indications for many antidepressants currently available in the general population, little is known about the clinical indications of these agents in SCI. This study is proposed to test the benefits of Venlafaxine HCI (Effexor XR) for reducing mild to moderate symptoms of depression among people with SCI. The intervention will last 12 weeks and there will be 13 assessments and data collection points. Data will be collected at 26 weeks also. Eight face to face contacts are anticipated.
Because of the change in protocol to reducing mild to moderate symptoms and substantially lower enrollment than anticipated (1/6th of what we anticipated), we deleted a number of study outcomes listed in the 2011 posting of this study. Most of these were not part of the original posting in 2008, and those that were deleted were no longer relevant to new protocol's focus on reducing mild to moderate depression. The two outcomes reported here were most relevant to the revised protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Having sustained an SCI at least six months prior to enrollment.
- •Neurological impairment ASIA Grades A-D.
- •Mild to moderate depressive symptoms.
- •English speaker
- •Age 18 years or older
- •Able to communicate with study personnel
排除标准
- •No neurological impairment due to SCI.
- •Presence of cognitive deficits precluding and giving informed consent and completion of survey based assessment tools.
- •Psychiatric contraindications (suicidal ideation, history of suicidal attempts, alcohol and drug dependency, other psychiatric diagnosis including bipolar disorder).
- •Medical contraindications (terminal illness or unstable medical condition as determined by medical history and/or examination).
- •Pregnant or unwilling to use birth control if female and sexually active.
- •Presence of glaucoma.
- •Prior use of study drug without success or being treated with another antidepressant medication and being unwilling to taper off to take the stud drug.
- •Willing to travel to Ann Arbor Michigan.
- •Expecting to take or currently taking another experimental study within 30 days
- •Major surgery scheduled within 12 weeks
研究组 & 干预措施
Venlafaxine
Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
干预措施: Venlafaxine HCl (Drug)
Placebo
Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
干预措施: Placebo (Other)
结局指标
主要结局
16-Item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16)
时间窗: Baseline and Week 13
The QIDS assesses symptoms of depression across the nine DSM-IV criterion domains for major depressive episode. The primary end-point in this study was the number of participants who had a \>50% change in scores on the QIDs from baseline to week 13 (end of treatment period).
次要结局
- Depression Scale of the Patient Health Questionnaire (PHQ-9)(Baseline and weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks)
研究者
Denise Tate
Professor
University of Michigan