Indicated Prevention With Long-chain Polyunsaturated Omega-3 Fatty Acids in Patients With 22q11 M… (NCT02070211) | Clinical Trial Compass
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 range12 Years – 26 Years
SexALL
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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.
What they're measuring
1
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 GesĂą Hospital and Research Institute