SchizophreniaNCT02552758
The Influence of Omega-3 Fatty Acid on the Violence of Schizophrenia Patient and the Possible Mechanism
A study testing omega-3 fatty acid and positron emission tomography (PET) in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- omega-3 fatty acid and positron emission tomography (PET)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- the sore of MOAS scale >=4 more than 2 violent behavior in recent 6 months by self repot
Who cannot join
- serious diseases,such as cardiovascular diseases,nervous system disease. allergy to fish oil
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Yi Qiao, phD, +8613817615936, qiaoyi2004@msn.com
About this study
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.
- Conditions
- Schizophrenia
- Being tested
- omega-3 fatty acid, placebo, positron emission tomography (PET)
- Keywords
- violence, PET, omega-3 fatty acid, schizophrenia, patient
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 fatty acidBiological
omega-3 fatty acid
placeboBiological
placebo
positron emission tomography (PET)Device
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 fatty acid | Experimental | omega-3 fatty acid Receives: Biological: omega-3 fatty acid; Device: positron emission tomography (PET) |
| placebo | Placebo comparator | placebo Receives: Biological: placebo; Device: positron emission tomography (PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
violent behavior of Participants as Assessed by Modified Overt Aggression Scale(MOAS)
change in violent behavior of participants
Measured: up to 24 months
psychiatry symptoms of participants as assessed by Positive and Negative Syndrome Scale (PANSS)
change in psychiatry symptoms of participants
Measured: 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
Measured: 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
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Qiao, phD, Principal investigator, Shanghai Mental Health Center (China)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552758
- Sponsor's protocol ID
- 2014-25
- Status last verified
- Sep 2015
- First submitted
- 8 Sep 2015
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Omega-3 Fatty Acid on the Violence of Schizophrenia Patient and the Possible Mechanism
- ClinicalTrials.gov ID
- NCT02552758
- Acronym / sponsor ID
- 2014-25
- Conditions
- Schizophrenia
- Keywords
- violence, PET, omega-3 fatty acid, schizophrenia, patient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 fatty acid | Experimental | Biological: omega-3 fatty acid, Device: positron emission tomography (PET)omega-3 fatty acid |
| placebo | Placebo comparator | Biological: placebo, Device: positron emission tomography (PET)placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- the sore of MOAS scale >=4 more than 2 violent behavior in recent 6 months by self repot
Key exclusion criteria (1 listed)
- serious diseases,such as cardiovascular diseases,nervous system disease. allergy to fish oil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omega-3 fatty acidomega-3 fatty acid | Biological | Omega-3 fatty acid |
| placeboplacebo | Biological | placebo |
| positron emission tomography (PET) | Device | Omega-3 fatty acid, placebo |
Primary outcome
violent behavior of Participants as Assessed by Modified Overt Aggression Scale(MOAS)
Time frame: up to 24 months
change in violent behavior of participants
psychiatry symptoms of participants as assessed by Positive and Negative Syndrome Scale (PANSS)
Time frame: up to 24 months
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
Time frame: 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
the density of 5-HT1A receptor in brain tested by positron emission tomography (PET)
Time frame: up to 24 months
change of the density of 5-HT1A receptor in different groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Qiao, phD principal investigator
Shanghai Mental Health Center (China)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omega-3 fatty acid and positron emission tomography (PET) in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Qiao, phD (+8613817615936, qiaoyi2004@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
violent behavior of Participants as Assessed by Modified Overt Aggression Scale(MOAS) (time frame: up to 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2015.