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

Primary Purpose

Schizophrenia

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

omega-3 fatty acid

placebo

positron emission tomography (PET)

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring violence, PET, omega-3 fatty acid, schizophrenia, patient

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Omega-3 fatty acid

placebo

Arm Description

omega-3 fatty acid

placebo

Outcomes

Primary Outcome Measures

violent behavior of Participants as Assessed by Modified Overt Aggression Scale(MOAS)

change in violent behavior of participants

psychiatry symptoms of participants as assessed by Positive and Negative Syndrome Scale (PANSS)

change in psychiatry symptoms of participants

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02552758

First Posted

September 8, 2015

Last Updated

September 16, 2015

Sponsor

Shanghai Mental Health Center

1. Study Identification

Unique Protocol Identification Number

NCT02552758

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Unknown status

Study Start Date

May 2015 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Mental Health Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

violence, PET, omega-3 fatty acid, schizophrenia, patient

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Omega-3 fatty acid

Arm Type

Experimental

Arm Description

omega-3 fatty acid

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

placebo

Intervention Type

Biological

Intervention Name(s)

omega-3 fatty acid

Intervention Description

omega-3 fatty acid

Intervention Type

Biological

Intervention Name(s)

placebo

Intervention Description

placebo

Intervention Type

Device

Intervention Name(s)

positron emission tomography (PET)

Primary Outcome Measure Information:

Title

violent behavior of Participants as Assessed by Modified Overt Aggression Scale(MOAS)

Description

change in violent behavior of participants

Time Frame

up to 24 months

Title

psychiatry symptoms of participants as assessed by Positive and Negative Syndrome Scale (PANSS)

Description

change in psychiatry symptoms of participants

Time Frame

up to 24 months

Title

blood level of eicosapentaenoic acid(EPA), docosahexaenoic acid (DHA), noradrenalin(NE), dopamine(DA) and serotonin(5-HT) of participants

Description

change in the blood level of DHA, EPA, 5-HT, DA and NE at baseline, 4 weeks, 8 weeks and 12 weeks

Time Frame

up to 24 months

Title

the density of 5-HT1A receptor in brain tested by positron emission tomography (PET)

Description

change of the density of 5-HT1A receptor in different groups

Time Frame

up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yi Qiao, phD

Phone

+8613817615936

qiaoyi2004@msn.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yi Qiao, phD

Organizational Affiliation

Shanghai Mental Health Center (China)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Mental Health Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yi Qiao, phD

Phone

+8613817615936

qiaoyi2004@msn.com

12. IPD Sharing Statement

Learn more about this trial

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

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