A Controlled Trial of Venlafaxine XR for Major Depression After Spinal Cord Injury: A Multi-site Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 6
- 主要终点
- Hamilton Depression Rating Scale-17
研究概览
简要总结
Depression is likely the most prevalent and disabling psychological complication associated with spinal cord injury (SCI). Yet no controlled depression treatment trials have been performed in this population. The proposed study is a multi-site, randomized, double-blind, placebo controlled trial of venlafaxine XR (Effexor XR) in 133 adults with SCI and major depressive disorder (MDD) or dysthymia who are at least one month post injury. Participants will be recruited from four SCI Model System sites, the University of Washington, Rehabilitation Institute of Chicago, University of Michigan, University of Alabama, Birmingham and Baylor Institute for Rehabilitation, Dallas, TX. The purpose of the study is to examine the efficacy and tolerability of venlafaxine XR as a treatment for MDD. The primary outcome will be the percent of responders (those who report at least a 50% reduction in depression severity from baseline to the end of treatment) in the venlafaxine XR versus placebo control group using intent-to-treat analysis. Secondary outcomes will include changes in pain, health related quality of life depression-related disability and community participation. A successful clinical trial could lead to more aggressive identification and treatment of MDD as well as improved health and quality of life in this important population.
详细描述
Depression is likely the most prevalent and disabling psychological complication associated with spinal cord injury (SCI). The prevalence of major depression in people with SCI is 22% or two to six times higher than in the general population. Depression is linked to a myriad of adverse outcomes including poor subjective health, poor community integration, higher rates of medical complications and high rates of suicide. Surprisingly there are no randomized controlled trials for treating major depressive disorder (MMD) in people with SCI. Despite the widespread use of antidepressants in this population, the common assumption that antidepressant medications are effective and well-tolerated among people with SCI is uncertain. Multiple factors such as severe stresses, bereavement and loss of rewarding activities may complicate treatment. Treatment trials suggest antidepressants may not be as effective in people with medical/neurological conditions as they are with depression that develops as a primary condition. For almost 20 years clinicians and scientists have called for controlled clinical trials of antidepressants among people with SCI in order to establish evidence-based treatment. The proposed study is a multi-site, randomized, double-blind, placebo controlled trial of venlafaxine XR (Effexor XR) in 133 adults with SCI and MDD or dysthymia who are at least one month post injury. Participants aged 18-64 will be recruited from four SCI Model System sites, the University of Washington, Rehabilitation Institute of Chicago, University of Michigan, University of Alabama, Birmingham and Baylor Institute for Rehabilitation, Dallas TX. The purpose of the study is to examine the efficacy and tolerability of venlafaxine XR as a treatment for MDD. The primary outcome will be the percent of responders (those who report at least a 50% reduction in depression severity from baseline to the end of treatment) in the venlafaxine XR versus placebo control group using intent-to-treat analysis. Secondary outcomes will include changes in pain, health related quality of life and participation. A successful clinical trial could lead to more aggressive identification and treatment of MDD as well as improved health and quality of life in this important population.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal cord injury (ASIA A-D)
- •At least one month post injury
- •Meets DSM IV criteria for major depression or dysthymia on the SCID
- •At least moderately severe depression (PHQ-9 score >= 10)
- •Within reasonable travel distance to one of the study sites
排除标准
- •Current DSM IV alcohol or drug dependence
- •History of bipolar disorder or psychosis
- •History of >= 2 suicide attempts or suicide attempt with 5 years
- •Current suicidal intent or plan
- •Medical contraindications
- •Non-English speaker
- •Clinically significant cognitive/language impairment
- •History of allergic reaction to venlafaxine XR or use of MAO-I with 2 weeks
- •Current use of antidepressant medications (will not exclude if on low dose of a tricyclic antidepressant or trazodone for pain, sleep, or bladder), psychotherapy for depression, or electroconvulsive therapy
- •Pregnant or lactating women or women of childbearing potential who are not willing to use a reliable form of contraception
- •Unstable medical condition, as determined by physical examination, CBC w/ platelets (including hematocrit, hemoglobin, WBC, differential), serum chemistry panel (serum sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose), liver transaminases (AST, ALT), thyroid stimulating hormone (TSH), urinalysis, supine diastolic blood pressure (SDBP) > 90 mm Hg, or near terminal illness (primary care physician estimates that patient has < 1 year to live)
- •Anticipated major surgical procedures within the 12 weeks of randomization
- •Use of an investigational drug within 30 days
- •Use of psychoactive medications, including corticosteroids and anticonvulsants, that have not been at a stable dose for at least 2 weeks
- •Use of anxiolytic, sedative-hypnotic, or other psychotropic drug or substance (including St. John's Wort) within 7 days of start of double-blind treatment. If the patient is taking a sedative deemed necessary for sleep induction or spasticity, the dosage must have been stable for at least 2 weeks. Use of anticholinergic, low-dose tricyclic antidepressant, GABAergic or adrenergic medications for spasticity are permitted if at a stable dose for at least 2 weeks.
- •Refusal to participate
研究组 & 干预措施
placebo
identically encapsulated placebo pills 37.5 - 300 mg/day for 12 weeks
干预措施: placebo (Drug)
venlafaxine XR
venlafaxine XR 37.5 - 300 mg/day for 12 weeks
干预措施: venlafaxine XR (Drug)
结局指标
主要结局
Hamilton Depression Rating Scale-17
时间窗: 0 weeks, 12 weeks
The 17-item Hamilton Depression Rating Scale is a clinician rated measure of depression severity (we used a structured interview version (Williams 1988) to improve inter-rater reliability). Scores range from 0-52. Higher scores indicate more severe depression. Scores of 7 or less indicate remission from depression.
Hamilton Depression Rating Scale-Maier Subscale
时间窗: 0 weeks, 12 weeks
The Maier is a 6-item sub scale of the Hamilton derived from Rasch analysis. It is a unidimensional scale with superior sensitivity to change. It excludes somatic items and is therefore especially appropriate for individuals who have substantial physical impairment and medical comorbidity. Scores can range from 0-22 with higher scores indicating more severe depression. Scores of 4 or less indicated in remission from depression.
次要结局
- Side Effects Checklist(Weeks 0, 1, 3, 6, 8, 10, 12)
- Symptom Checklist-20 Depression Subscale(Weeks 0, 1, 3, 6, 8, 10, 12, 24)
- Modified Ashworth Spasticity Scale(Weeks 0, 1, 3, 6, 8, 10, 12)
- Craig Handicap and Reporting Technique(Weeks 0, 12)
- Sheehan Disability Scale(Weeks 0, 12)
- Hamilton Rating Scale for Anxiety(Weeks 0, 12)
- SF-12(Weeks 0, 12, 24)
- Clinical Global Impression(Weeks 0, 1, 3, 6, 8, 10, 12)
- Patient Global Impression(Weeks 0, 1, 3, 6, 8, 10, 12)
- Modified Brief Pain Inventory(Weeks 0, 1, 3, 6, 8, 10, 12)
- Structured Clinical Interview for DSM IV Depression Module(Weeks 0, 12, 24)
- Satisfaction With Life(Weeks 0, 12)
研究者
Charles Bombardier
Primary Investigator
University of Washington