Treating Adolescent Depression With Fish Oils
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Hamilton Depression Rating Scale
研究概览
简要总结
Adolescence is the highest risk period for depression onset. More than 1.3 million youths suffer from major depression annually in the United States, and there is evidence for an increasing trend. Because many adolescents have their first depressive episode in adolescence and adolescent depression often leads to recurrent mood disorders in adults, effective treatment during early illness can minimize the negative consequences of initial and repeated episodes. Although some antidepressants (particularly Selective serotonin reuptake inhibitors (SSRIs)) are effective treatments for juvenile depression, recent warnings about suicide and the use of SSRls highlight the need for new and safe treatment for juvenile depression. Data in adults suggest that supplementation with polyunsaturated fatty acids (PUFA) might be useful for the treatment of depression. The purpose of this study is to investigate the safety and efficacy of PUFA for the treatment of adolescent depression.
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
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents between the ages of 13 and 21 currently under standard of care treatment at the Child Division of the Department of Psychiatry at CSMC
- •Diagnosed with major depressive disorder using the DSM-IV diagnostic criteria
排除标准
- •Active suicidal ideation, with a current plan and/ or a recent suicide attempt
- •Severe psychotic symptoms (presence of distressing or common hallucinations and/ or delusions)
- •History of bipolar disorder, eating disorder, schizophrenia, schizoaffective disorder, or autism
- •Potential subjects using psychotropic medication(s), alcohol, and/ or drugs within 2 weeks prior to entry into the study (8 weeks for fluoxetine and MAOIs - monoamine oxidase inhibitors)
- •Pregnant or lactating females, or those who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy) and become pregnant
- •Seizure or other neurological disorders
- •Dermatological conditions
- •Unstable cardiac, pulmonary, endocrine, or renal disorder
- •Adolescents who are currently being effectively treated with antidepressants
结局指标
主要结局
Hamilton Depression Rating Scale
时间窗: 8 times for an average of 8 weeks
Child Depression Inventory - CDI
时间窗: 8 times for an average of 8 weeks
次要结局
未报告次要终点