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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02552758
• Other study ID #: 2014-25
• Status: Recruiting
• Phase: N/A
• First received: September 8, 2015
• Last updated: September 16, 2015
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: September 2015
• Source: Shanghai Mental Health Center
• Contact: Yi Qiao, phD
• Phone: +8613817615936
• Email: qiaoyi2004[@]msn.com
• Is FDA regulated: No
• Health authority: China: Shanghai Mental Health Center
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Biological:
• omega-3 fatty acid
omega-3 fatty acid
• placebo
placebo

Device:
• positron emission tomography (PET)

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	violent behavior of Participants as Assessed by Modified Overt Aggression Scale(MOAS)	change in violent behavior of participants	up to 24 months	No
Primary	psychiatry symptoms of participants as assessed by Positive and Negative Syndrome Scale (PANSS)	change in psychiatry symptoms of participants	up to 24 months	No
Primary	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	No
Primary	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	No