The Influence of Omega-3 Fatty Acid on the Violence of Schizophrenia Patient and the Possible Mechanism
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable schizophrenia
Started May 2015
Shorter than P25 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 8, 2015
CompletedFirst Posted
Study publicly available on registry
September 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedSeptember 17, 2015
September 1, 2015
1.6 years
September 8, 2015
September 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Omega-3 fatty acid
EXPERIMENTALomega-3 fatty acid
placebo
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
You may qualify if:
- the sore of MOAS scale \>=4 more than 2 violent behavior in recent 6 months by self repot
You may not qualify if:
- serious diseases,such as cardiovascular diseases,nervous system disease. allergy to fish oil
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi Qiao, phD
Shanghai Mental Health Center (China)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2015
First Posted
September 17, 2015
Study Start
May 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
September 17, 2015
Record last verified: 2015-09