The Influence of Omega-3 Fatty Acid on the Violence of Schizophrenia Patient and the Possible Mechanism

Study Overview
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Brief Summary
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Investigators plan to explore whether Omega-3 fatty acid have effect on the violent behavior of the schizophrenia patients. Investigators will use PET to explore the influence on serotonin function of the brain to understand the mechanism of how Omega-3 fatty acid works. This study will enroll 100 patients of schizophrenia with violent behavior.Participants will be split into two groups randomly. In one group, participants will receive one pill of placebo per day, and in the other, participants will have one pill of 900mg Omega-3 fatty acid per day. This intervention will last 3 months.At week 0, week 4, week 8 and week 12, some scales will be evaluated. Meanwhile, the density of eicosapentaenoic acid(EPA),docosahexaenoic acid (DHA),noradrenalin(NE), dopamine(DA) and serotonin(5-HT) in blood will be tested.At week 0 and week 12, 10 patients of each group will be randomly selected to have the exam of PET.

Official Title
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The Influence of Omega-3 Fatty Acid on the Violence of Schizophrenia Patient and the Possible Mechanism

Conditions
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Schizophrenia

Intervention / Treatment
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* Biological: omega-3 fatty acid
* Biological: placebo
* Device: positron emission tomography (PET)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the sore of MOAS scale >=4 more than 2 violent behavior in recent 6 months by self repot Exclusion Criteria: serious diseases,such as cardiovascular diseases,nervous system disease. allergy to fish oil

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3 fatty acid<br>omega-3 fatty acid | Biological: omega-3 fatty acid<br>* omega-3 fatty acid<br>Device: positron emission tomography (PET)<br> <br> |
| Placebo Comparator: placebo<br>placebo | Biological: placebo<br>* placebo<br>Device: positron emission tomography (PET)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| violent behavior of Participants as Assessed by Modified Overt Aggression Scale(MOAS) | change in violent behavior of participants | up to 24 months | 
| psychiatry symptoms of participants as assessed by Positive and Negative Syndrome Scale (PANSS) | change in psychiatry symptoms of participants | up to 24 months | 
| blood level of eicosapentaenoic acid(EPA), docosahexaenoic acid (DHA), noradrenalin(NE), dopamine(DA) and serotonin(5-HT) of participants | change in the blood level of DHA, EPA, 5-HT, DA and NE at baseline, 4 weeks, 8 weeks and 12 weeks | up to 24 months | 
| the density of 5-HT1A receptor in brain tested by positron emission tomography (PET) | change of the density of 5-HT1A receptor in different groups | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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violence, PET, omega-3 fatty acid, schizophrenia, patient