A Randomized, Double-Blind Placebo-controlled Study Evaluating the Efficacy of Omega 3 Fatty Acid Augmentation of Desvenlafaxine for the Treatment of Major Depressive Disorder in Patients With Medical Illness.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Hospital Anxiety and Depression Scale
研究概览
简要总结
To assess the efficacy of Omega 3 Fatty acid (Omega 3 FA) augmentation of desvenlafaxine (DVS) compared to placebo augmentation of DVS when used to treat depression and anxiety symptoms in patients with select medical conditions (cancer, cardiovascular diseases and diabetes).
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
- •18 years of age or older
- •Diagnosed with depression and have cardiovascular disease, diabetes or cancer.
- •Able to provide written informed consent prior to initiation of any study-related procedures.
- •Able to understand and comply with the requirements of the study.
排除标准
- •Hospitalized patients or psychotherapy for depression begun within 4 weeks.
- •Patients with medically reversible causes of depression (e.g. hypothyroidism).
- •Patients with significant comorbid symptoms (e.g. pain, insomnia) that have a direct causal relation to depressive and anxiety symptoms with these comorbid symptoms dominating the clinical scenario. Patients will be enrolled in the study if these comorbid symptoms merely coexist with depressive and anxiety symptoms and are not dominating the clinical scenario as judged by the study investigator
- •Patients with an identifiable diagnosis of substance abuse or dependence within 6 months prior to evaluation (except those in full remission, or those with caffeine or nicotine dependence) as defined by DSM-IV criteria.
- •Patients with any clinically significant unstable or inadequately treated co-morbid medical condition which, in the opinion of the investigator, would make the patient unsuited for the study
- •Patients with currently active or with significant history of other clinically significant psychiatric disorders such as bipolar disorder, schizophrenia etc.
- •Pregnant patients, breastfeeding or those planning to become pregnant during the study.
- •Any other condition, which, in the opinion of the investigator, would make the patient, unsuited for enrollment in the study, including known or suspect history of allergy to fish oil, fish or desvenlafaxine.
研究组 & 干预措施
Desvenlafaxine + Omega 3 FA supplement
Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period
干预措施: Desvenlafaxine (Drug)
Desvenlafaxine + Omega 3 FA supplement
Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period
干预措施: Omega 3 Fatty acids (Dietary Supplement)
Desvenlafaxine + Placebo (for Omega 3 FA supplement)
Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period
干预措施: Desvenlafaxine (Drug)
Desvenlafaxine + Placebo (for Omega 3 FA supplement)
Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period
干预措施: Placebo (for Omega 3 fatty acid supplement) (Drug)
结局指标
主要结局
Hospital Anxiety and Depression Scale
时间窗: 12 weeks from baseline
Hospital Anxiety and Depression Scale: This is a validated scale for measuring depression/anxiety symptoms in patients with medical conditions.
次要结局
- Montgomery-Asberg Depression Rating Scale (MADRS)(12 weeks from baseline)
- Leeds Sleep Evaluation Questionnaire (LSEQ)(12 weeks from baseline)
- Short Form Health Survey (SF-12)(12 weeks from baseline)
- Visual Analog Scale for Energy (VAS-E)(12 weeks from baseline)
- Visual Analog Scale for Pain (VAS-P)(12 weeks from baseline)