UnknownPhase 2/3

Indicated Prevention With Long-chain Polyunsaturated Omega-3 Fatty Acids in Patients With 22q11 Microdeletion Syndrome.

Holy See80 participantsStarted 2014-06

Plain-language summary

The purpose of the present trial is to investigate the effects of omega-3 PUFAs in individuals aged 12-26 years with 22q11DS at ultra-high risk for developing a first episode of psychosis.

Who can participate

Age range

12 Years – 26 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * written informed consent (for individuals under 18 written informed consent of parents is required); * age between 12 and 26 years; * UHR as classified by the CAARMS (Yung et al., 2005); * genetic diagnosis of 22q11DS Exclusion Criteria: * acute suicidal behaviour (score of 6 on CAARMS item 7.3) or aggressive behaviour (score of 6 on CAARMS item 5.4); * Drug abuse that contributed decisively to the presentation of the index episode, (dependency on morphine, cocaine, amphetamine, but not THC); * Alcohol abuse if considered as major problem; * Epilepsy; 5./IQ\<70); * Pregnancy and lactation; * Previous history of antipsychotic drug treatment (\> one week treatment); * Laboratory values more than 15% outside the normal range for transaminases, CRP or bleeding parameters; * Individuals with organic brain syndrome; * Individuals who are taking anticoagulants; * Individuals who are taking omega-3 supplements, currently or within 8 weeks of being included in the trial; * Individuals who have other, severe, intercurrent illness which in the opinion of the investigator may put them at risk or influence the results of the trial.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The primary outcome measure for this study is the transition to psychosis rate measured by the Comprehensive Assessment of At Risk Mental States (CAARMS) (Yung et al., 2005),

Timeframe: The time frame for the first outcome measure will be over the 12-month follow-up period.

Trial details

NCT IDNCT02070211

SponsorBambino Gesù Hospital and Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06

Contact for this trial

Marco Armando, MD, PhD

+39 06 6859 2030 marco.armando@opbg.net

View on ClinicalTrials.gov More 22q11 Deletion Syndrome trials

Who can participate

Age range

12 Years – 26 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.