NCT00067301已完成3 期
PUFA Augmentation in Treatment of Major Depression
National Center for Complementary and Integrative Health (NCCIH)2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2003年9月最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to determine if omega-3 fatty acid EPA will enhance and speed up response to antidepressant therapy with Celexa (Citalopram) in people suffering from Major Depressive Disorder. All patients will receive Celexa, 50% will receive EPA, 50% placebo EPA.
详细描述
As per brief summary
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
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet DSM-IV criteria for current major depression, and have a HAM-D (21 item) score of > 17
- •Male or female who, if of child-bearing potential, agrees to use effective contraception including the regular use of contraceptive pills, intra-uterine devices, barrier methods or abstinence
- •Age between 18 and 65
- •Capable of giving informed consent
排除标准
- •Diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression or bipolar disorders
- •Current drug or alcohol abuse or dependence, or history of drug or alcohol abuse or dependence within the previous 6 months
- •Unstable medical or neurological conditions that are likely to interfere with the treatment of depression
- •History of allergy to citalopram or ProEPA, finfish or shellfish
- •History of failure of response to citalopram, as documented by an adequate trial of the medication [defined as having been treated with the medication at a dose level typically regarded as adequate (i.e., 40 mg of citalopram per day) for at least 6 weeks]
- •History of seizure disorder
- •Pregnancy
- •Currently on psychotropic medications including antidepressants or neuroleptics
- •Active suicidal ideation or other safety issues determined by the clinician to not be suitable for inclusion in the study
- •Exposure to treatment with fluoxetine or MAOIs in the previous two months
- •Patients on anticoagulant therapy
- •Patients with a dietary intake of > 3.0g total omega-3 PUFA/day at baseline
研究者
研究点 (2)
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