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

Not Applicable

• Conditions: Schizophrenia
• Interventions: Biological: placebo; Biological: omega-3 fatty acid; Device: positron emission tomography (PET)

• Registration Number: NCT02552758
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Status Verified: 2015-09
• Study First Submitted: 2015-09-08
• Study First Submitted QC: 2015-09-16
• Last Update Submitted: 2015-09-16
• Study First Posted: 2015-09-17
• Last Update Posted: 2015-09-17
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	positron emission tomography (PET)	placebo
Omega-3 fatty acid	positron emission tomography (PET)	omega-3 fatty acid
placebo	placebo	placebo
Omega-3 fatty acid	omega-3 fatty acid	omega-3 fatty acid

Primary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China