Randomized Trial of Sertraline Treatment of Depression in Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score.
研究概览
简要总结
This is a randomized double-blinded placebo-controlled trial to see if treatment with sertraline as compared with placebo tablets will improve depression symptoms in patients with chronic kidney disease who have not yet started dialysis or received a kidney transplant. The investigators will also investigate whether sertraline treatment will improve quality of life and whether it is safe to use in patients with kidney disease. The study subject will be randomly assigned to take either sertraline or a placebo tablet for 12 weeks.
详细描述
This is a randomized double-blinded placebo-controlled trial of adults with predialysis stages 3-5 Chronic Kidney Disease and Major Depressive Episode. Subjects will be randomized in a double-blind fashion to placebo or sertraline (beginning at 50 mg/d and escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d) and followed for 12 weeks. The primary outcome is to investigate if treatment with sertraline, as compared with placebo, results in an improvement in depression symptom severity as measured by the Quick Inventory of Depressive Symptomatology Clinician Rated (QIDS-C-16) score. Secondary outcomes include whether sertraline, as compared with placebo, improves overall function and quality of life and whether it will result in more serious adverse events.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults aged greater than 21 years.
- •Predialysis stages 3, 4 or 5 CKD.
- •Current Major Depressive Episode.
- •QID-C-16 score of
- •Able to understand and sign informed consent.
排除标准
- •No healthcare power of attorney to sign informed consent.
- •Unwilling or unable to participate.
- •Kidney transplant recipient.
- •Initiated on maintenance dialysis
- •Significant hepatic dysfunction or liver enzyme abnormalities 3 times the upper limits of normal.
- •Terminal chronic obstructive pulmonary disease or cancer.
- •Recent history of active bleeding, such as gastrointestinal bleeding requiring hospitalization 3 months prior
- •Current use of class I anti-arrhythmic medications.
- •Use of pimozide, MAO inhibitors, reserpine, guanethidine, cimetidine or methyldopa; tri-cyclic anti-depressants, neuroleptics or anti-convulsants, excluding gabapentin
- •Use of other serotonergic drugs or supplements such as triptans, tramadol, linezolid, tryptophan, and St. John's Wort.
- •Ongoing use of anti-depressants
- •Past treatment failure on Sertraline
- •Initiation of psychotherapy for depression in the 3 months prior to study entry
- •Alcohol or substance abuse or dependence that requires acute detoxification at study entry
- •Present or past psychosis or Bipolar I or II disorder
- •Dementia or a Mini-Mental State Examination score of <23
- •Suicidal ideation
- •Pregnancy, lactation and women of childbearing potential not using adequate contraception
研究组 & 干预措施
Sertraline
Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode
干预措施: Sertraline (Drug)
Placebo
Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score.
时间窗: baseline to 12 weeks
The score range is 0 to 27; higher scores indicate more severe depression; a score of 0 to 5 corresponds to a normal affect; 6 to 10 to a mild affect; 11 to 15 to a moderate affect; 16 to 20 to a severe affect; and 21 or greater to very severe depression.
次要结局
- Serious Adverse Events During the 12 Week Study Duration.(during 12 week study duration)
- Change in Quality of Life From Baseline to Exit in the Kidney Disease Quality of Life -Short Form, Version 1.3, Patient-reported Overall Health.(baseline to 12 weeks)
- Response to Treatment Defined as a Decline of 50% in the Baseline QIDS-C-16 Score and Remission of Depression Defined as a QIDS-C-16 Score of 5(baseline to 12 weeks)
- Change From Baseline to Exit in Overall Function as Assessed by the Work and Social Adjustment Scale(baseline to 12 weeks)