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临床试验/NCT00917501
NCT00917501已完成2 期

Neurochemical Effects of Omega-3 Fatty Acids in Adolescents at Risk for Mania

University of Cincinnati1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2009年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
55
试验地点
1
主要终点
Change From Baseline in Depression Symptom Severity at 12 Weeks

研究概览

简要总结

The purpose of this study is to see if taking a substance called omega-3 fatty acids is effective, safe, and well-tolerated for treating adolescents with major depressive disorder (also called simply "depression" or "clinical depression"). Another purpose of this study is to see how much omega-3 fatty acids are in a patient's blood and if that makes the patient more or less likely to develop mania (i.e. periods of irritability or extreme silliness accompanied by decreased need for sleep, risky behaviors, feeling like the patient has special abilities, inability to sit still, and rapid speech) in the future. Yet another purpose of this study is to see how taking omega-3 fatty acids affect brain scans. Omega-3 fatty acids are not United States Food and Drug Administration (FDA)-approved to treat depression in adults or in children and adolescents.

Omega-3 fatty acids can only be obtained through diet, most often from fish and other sea foods, though they are also found in other food sources such as flax seed. Omega-3 fatty acids have been shown to play a role in affecting brain chemicals responsible for regulating mood and have been found to reduce symptoms of depression in medicated-patients with major depressive disorder.

By completing this study, the investigators hope to better understand who benefits from treatment, why they do or do not respond to medications, and who is at greater risk for developing further mental illness. With this information, the investigators hope to be able to improve treatment and outcome in people with major depressive disorder.

详细描述

A. Specific Aims: (1) To collect pilot data regarding the efficacy, safety, and tolerability of omega-3 fatty acid supplementation for the treatment of adolescents with active depressive symptoms and a high risk for developing mania (i.e. the patient has a bipolar parent and meet DSM-IV-TR criteria for major depressive disorder). (2) To use proton magnetic resonance spectroscopy (1H MRS) (i.e. prefrontal neurochemistry) and red blood cell (RBC) omega-3 fatty acid levels to examine potential mediators of treatment response to omega-3 fatty acids in adolescents with a high risk for mania.

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 (Participant, Investigator)

入排标准

年龄范围
10 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo to the Omega-3 given in other group taken twice a day.

干预措施: Placebo (Drug)

Omega 3

Active Comparator

Individual omega-3 capsules contain 400 mg EPA and 200 mg DHA & will be taken twice a day.

干预措施: OMega 3 (Drug)

结局指标

主要结局

Change From Baseline in Depression Symptom Severity at 12 Weeks

时间窗: Baseline and 12 weeks

Change in Children's Depression Rating Scale-revised (CDRS-R) Total Score from Baseline to 12 weeks CDRS-R score ranges from 17 (i.e., not depressed) to 113 (i.e., severe depression)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert McNamara

Professor

University of Cincinnati

研究点 (1)

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