NCT00585390已完成2 期
Randomized, Double-Blind, Placebo-Controlled Pilot Trial of Essential Fatty Acid Deficiency Replacement in Early Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Determine positive symptom treatment response in omega-3 fatty acid deficient first-episode schizophrenia patients augmented with omega-3 fatty acid supplementation vs. placebo.
研究概览
简要总结
The purpose of this research study is to find out what effects (good and bad) that omega-3 fatty acids has on schizophrenia.
详细描述
The two aims of the study test the hypotheses that correcting omega-3 fatty acid deficiency in the early stages of schizophrenia improves positive symptom treatment response, negative symptom treatment response, and cognition symptom response.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 8-25 years.
- •Diagnosis of MDD and not exhibited symptom remission CDRS-R (> 28 but < 40) despite being administered a standard therapeutic dose of an SSRI continuously for a minimum of 6 weeks.
- •Ability and willingness to provide assent and informed, written consent from at least one biological parent.
- •Present with biological parent or legal guardian.
- •Willingness to maintain current dietary habits.
- •Permission from treating physician
- •Able to perform fMRI/MRS.
排除标准
- •Inability or unwillingness to provide consent.
- •Antecedent or concurrent serious medical illness.
- •Clinically unstable medical disease, including cardiovascular, hepatic insufficiency, severe renal impairment, gastrointestinal, pulmonary, metabolic, endocrine, obesity or other systemic disease.
- •History of seizures, excluding febrile seizures in childhood.
- •Patients requiring treatment with any drug which might obscure the action of the study treatment.
- •Female patients who are either pregnant or lactating.
- •Clinically significant laboratory abnormalities in the last year on CBC or TSH tests.
- •Judged clinically to be at suicidal risk (defined as having active suicidal ideation, intent or plan, or a serious suicide attempt within the past 6 months, or a baseline CDRS-R suicide score of >3).
- •Hospitalized within the last 3 months
- •Greater than 1 year outside appropriate age/grade level
- •Pacemaker
- •Cerebral aneurysm clip
- •Cochlear implant
- •Metal fragments lodged within the eye or braces
- •Claustrophobia
- •Necessity of sedation (no sedation will be given).
- •History of loss of consciousness > 10 minutes in duration
- •Allergy to seafood.
研究组 & 干预措施
Essential omega-3 fatty acid replacement
Experimental
干预措施: Omega-3 Fatty Acids (Dietary Supplement)
Essential omega-3 fatty acid replacement
Experimental
干预措施: EPA fish oil concentrate; DHA fish oil concentrate (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Olive oil placebo (Other)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Determine positive symptom treatment response in omega-3 fatty acid deficient first-episode schizophrenia patients augmented with omega-3 fatty acid supplementation vs. placebo.
时间窗: 12 months
次要结局
- Determine negative and cognitive symptom treatment response in omega-3 fatty acid deficient first-episode schizophrenia patients augmented with omega-3 supplementation vs. placebo.(12 months)
研究者
研究点 (1)
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