EUCTR2008-005004-13-AT进行中（未招募）不适用
Add-on Therapie mit Omega-3 Fettsäuren bei Jugendlichen mit hohem Risikofür Schizophrenie und andere psychotische Störungen: eine Multizentren-ReplikationsstudieOmega-3 Fatty Acids for Symptomatic Patients at Ultra-High Risk for Early Progression to Schizophrenia and Other Psychotic Disorders: A Multicentre ReplicationStudy - Omega-3 fatty acids for indicated prevention of psychotic disorders
Orygen Research Centre0 个研究点目标入组 320 人开始时间: 2010年10月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion criteria
- •A. General inclusion criteria:
- •i. Ability to give informed consent
- •ii. Age 13-25 years
- •B. Membership of one of the following three ‘at-risk’ groups:
- •i. Attenuated Psychotic Symptoms Group (APS) Individuals with subthreshold (intensity or frequency) positive psychotic symptoms. The symptoms must have been present during the past year and be associated with a significant reduction in functioning.
- •ii. Brief Limited Intermittent Psychotic Symptoms Group (BLIPS) Individuals with a recent history of frank psychotic symptoms that resolved spontaneously (without antipsychotic medication) within one week. The symptoms must have been present during the past year and be associated with a significant reduction in functioning.
- •iii. Trait and State Risk Factor Group Individuals with a combination of a trait risk factor (such as schizotypal personality disorder or a family history of psychotic disorder in a first degree relative) and a significant deterioration in mental state and/or functioning for at least one month at the time of intake. Operationalized intake criteria based on the Comprehensive Assessment of At-Risk Mental State (CAARMS; Yung et al, 1998) are presented in Table 1.
- •Table 1: Operationalized intake criteria
- •Group 1: Attenuated Psychotic Symptoms Group
- •1a) Subthreshold intensity:
- •Intensity: Severity Scale Score of 3-5 on Disorders of Thought Content subscale, 3-4 on Perceptual Abnormalities subscale and/or 4-5 on Disorganised Speech subscales of the CAARMS
- •Frequency: Frequency Scale Score of 3-6 on Disorders of Thought Content, Perceptual Abnormalities and/or Disorganised Speech subscales of the CAARMS
- •Duration : symptoms present for at least one week
- •Recency: symptoms present in past year
- •Impact: SOFAS score currently and for the last month a at least 30% below previous level of functioning .
- •1b) Subthreshold frequency:
- •Intensity: Severity Scale Score of 6 on Disorders of Thought Content subscale, 5-6 on Perceptual Abnormalities subscale and/or 6 on Disorganised Speech subscales of the CAARMS
- •Frequency: Frequency Scale Score of 3 on Disorders of Thought Content, Perceptual Abnormalities and/or Disorganised Speech subscales of the CAARMS
- •Duration: symptoms present for at least one week
- •Recency: symptoms present in past year
- •Impact: SOFAS score currently and for the last month a at least 30% below previous level of functioning .
- •Group 2: BLIPS Group
- •Intensity: Severity Scale Score of 6 on Disorders of Thought Content subscale, 5 or 6 on Perceptual Abnormalities subscale and/or 6 on Disorganised Speech subscales of the CAARMS
- •Frequency: Frequency Scale Score of 4-6 on Disorders of Thought Content, Perceptual Abnormalities and/or Disorganised Speech subscales
- •Duration: Symptoms present for less than one week and spontaneously remit.
- •Recency: symptoms present in past year
- •Impact: SOFAS score currently and for the last month a at least 30% below previous level of functioning
- •Group 3: Vulnerability Group
- •Family history of psychosis in first degree relative OR Schizotypal Personality Disorder (as defined by DSM IV) in identified patient
- •Recency: Change in functioning occurred within last year
- •Impact: SOFAS score currently and for the last month a at least 30% below previous level of functioning
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subje
排除标准
- •Exclusion criteria include:
- •i. Past history of a treated or untreated psychotic episode of one week’s duration or
- •ii. Organic brain disease, e.g. epilepsy, inflammatory brain disease
- •iii. Abnormal coagulation profile parameters or thyroid function test results >10% above or below the limits of the normal range.
- •iv. Any physical illness with psychotropic effect, if not stabilized
- •v. Current treatment with lithium, methyl phenidate or ketamine, or recreational use of
- •vi. Past neuroleptic exposure equivalent to a total lifetime haloperidol dose of >50 mg.
- •[Refer to Appendix IV of the protocol for a list of equivalent doses for other neuroleptic agents.]
- •vii. Diagnosis of a serious developmental disorder, e.g. Asperger's syndrome
- •viii. Premorbid IQ < 70 and a documented history of developmental delay or intellectual
- •ix. Current aggression/dangerous behaviour (CAARMS 5.4 severity score 6)
- •x. Current suicidality/self harm (CAARMS 7.3 severity score 6)
- •xi. Current pregnancy
- •xii. Current attenuated symptoms that are entirely explained by acute intoxication (e.g., current attenuated symptoms entirely explained by LSD use).
- •xiii. > than 4 weeks of regular omega-3 supplementation (>2 capsules standard strength providing >600 mg combined EPA/DHA) within the last 6 months.
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