Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Change in depressive symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
This is a prospective, randomized clinical trial to investigate the clinical impact of a preemptive pharmacogenomics strategy to guide antidepressant therapy in cancer patients. Those enrolled onto the clinical trial will be randomized to either DNA-guided choice of therapy or clinical management alone. Scores on self-reported measures of depressive and anxiety symptoms along with quality of life will be compared between cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Patients will be blinded to the genomic results for 12 weeks, with the 12 week time period starting at the time of antidepressant drug prescribing.
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
- •Patients with a cancer diagnosis
- •Be 18 years of age or older
- •Patients who rate depression or anxiety > 5 based on a 10 point scale
- •Patients expected to live greater than 6 months
- •Serum bilirubin and creatinine < 1.5x upper limit of normal
- •AST and ALT < 3 times upper limit of normal
- •Willing and able to provide written informed consent
- •Able to complete self-assessment questionnaires
排除标准
- •Patients not diagnosed with cancer
- •Antidepressant prescribing performed by a non-Moffitt psychiatrist after enrollment onto the clinical trial
- •Known Pregnancy
- •History of liver or allogenic stem cell transplant
- •Patients with a known cognitive impairment (e.g., delirium, dementia, etc.) or psychological impairment (e.g., schizophrenia, bipolar disease, etc.) other than depressive and anxiety symptoms.
研究组 & 干预措施
DNA-guided choice of therapy
DNA-guided choice of antidepressant therapy
干预措施: DNA-guided choice of therapy (Diagnostic Test)
Clinical management
Clinical management
干预措施: DNA-guided choice of therapy (Diagnostic Test)
Clinical management
Clinical management
干预措施: Clinical management (Other)
结局指标
主要结局
Change in depressive symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS)
时间窗: Baseline, week 12, month 12
The Hospital Anxiety and Depression scale can range from 0 to 42 (14 questions each on a 0-3 point scale).
Change in anxious symptoms from baseline, as measured by the Hospital Anxiety and Depression Scale (HADS)
时间窗: Baseline, week 12, month 12
The Hospital Anxiety and Depression scale can range from 0 to 42 (14 questions each on a 0-3 point scale).
次要结局
- Quality of Life as measured by Functional Assessment of Cancer Therapy-General (FACT-G) Scale(12 months)