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Indicated prevention with long-chain polyunsaturated omega-3 fatty acids in patients with 22q11DS genetically at high risk for psychosis. Protocol of a randomized, double-blind, placebo-controlled treatment trial.
Early Interv Psychiatry. 2016 10; 10(5):390-6.EI

Abstract

AIM

It has been found that long-chain omega-3 polyunsaturated fatty acids (PUFAs) reduce the risk of progression to first episode of psychosis (FEP) and may offer a safe and efficacious strategy for selective and indicated prevention in young people with ultra-high-risk (UHR) states. An opportunity for exploring the trajectory of FEP and for investigating the efficacy of preventive treatments exists in 22q11.2 deletion syndrome (22q11DS), which has a 30% psychotic transition rate. The fact that 22q11DS patients are more homogeneous than other UHR groups and are characterized by high level of negative symptoms provides a strong rationale for the use of PUFAs. The principal aim of the present trial is to investigate the effects of PUFAs in individuals with 22q11DS who are at UHR for developing FEP.

METHODS

A prospective, randomized, double-blind, placebo-controlled, single-centre study design will be used. Eighty individuals aged 12-26 will be randomly assigned to two treatment conditions.

RESULTS

The experimental group will receive PUFAs. The placebo group will receive paraffin oil. Standard clinical assessments and neuropsychological tests will be performed at baseline and at 8-, 12-, 26- and 52-week follow-up. Blood samples will be collected at baseline and after 12 weeks. This study is registered as an International Standard RCT, number 02070211. The corresponding author is supported by a NARSAD Young Investigator Award.

CONCLUSIONS

This is the protocol of a planned study that aims to test the efficacy of PUFAs in the prodromal phase of FEP, in a specific syndrome where there is strong evidence that a high genetic load is involved in the disorder.

Authors+Show Affiliations

Child and Adolescence Neuropsychiatry Unit, Department of Neuroscience, Bambino Gesù Children's Hospital, Rome, Italy. marco.armando@opbg.net. School of Psychology, University of Birmingham, Birmingham, UK. marco.armando@opbg.net.Child and Adolescence Neuropsychiatry Unit, Department of Neuroscience, Bambino Gesù Children's Hospital, Rome, Italy.Child and Adolescence Neuropsychiatry Unit, Department of Neuroscience, Bambino Gesù Children's Hospital, Rome, Italy.Medical Genetic Unit, Pediatric Department, Bambino Gesù Children's Hospital, Rome, Italy.Child and Adolescence Neuropsychiatry Unit, Department of Neuroscience, Bambino Gesù Children's Hospital, Rome, Italy.Department of Neuroscience and Brain Technologies, Istituto Italiano di Tecnologia, Genova, Italy.Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria. Orygen Youth Health Research Centre, Centre for Youth Mental Health, University of Melbourne, Melbourne, Victoria, Australia.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25345540

Citation

Armando, Marco, et al. "Indicated Prevention With Long-chain Polyunsaturated Omega-3 Fatty Acids in Patients With 22q11DS Genetically at High Risk for Psychosis. Protocol of a Randomized, Double-blind, Placebo-controlled Treatment Trial." Early Intervention in Psychiatry, vol. 10, no. 5, 2016, pp. 390-6.
Armando M, De Crescenzo F, Vicari S, et al. Indicated prevention with long-chain polyunsaturated omega-3 fatty acids in patients with 22q11DS genetically at high risk for psychosis. Protocol of a randomized, double-blind, placebo-controlled treatment trial. Early Interv Psychiatry. 2016;10(5):390-6.
Armando, M., De Crescenzo, F., Vicari, S., Digilio, M. C., Pontillo, M., Papaleo, F., & Amminger, G. P. (2016). Indicated prevention with long-chain polyunsaturated omega-3 fatty acids in patients with 22q11DS genetically at high risk for psychosis. Protocol of a randomized, double-blind, placebo-controlled treatment trial. Early Intervention in Psychiatry, 10(5), 390-6. https://doi.org/10.1111/eip.12197
Armando M, et al. Indicated Prevention With Long-chain Polyunsaturated Omega-3 Fatty Acids in Patients With 22q11DS Genetically at High Risk for Psychosis. Protocol of a Randomized, Double-blind, Placebo-controlled Treatment Trial. Early Interv Psychiatry. 2016;10(5):390-6. PubMed PMID: 25345540.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Indicated prevention with long-chain polyunsaturated omega-3 fatty acids in patients with 22q11DS genetically at high risk for psychosis. Protocol of a randomized, double-blind, placebo-controlled treatment trial. AU - Armando,Marco, AU - De Crescenzo,Franco, AU - Vicari,Stefano, AU - Digilio,Maria Cristina, AU - Pontillo,Maria, AU - Papaleo,Francesco, AU - Amminger,G Paul, Y1 - 2014/10/24/ PY - 2014/04/02/received PY - 2014/09/16/accepted PY - 2014/10/28/entrez PY - 2014/10/28/pubmed PY - 2017/10/24/medline KW - 22q11 deletion syndrome KW - UHR KW - fatty acid KW - preventive treatment KW - psychotic disorder KW - randomized controlled trial SP - 390 EP - 6 JF - Early intervention in psychiatry JO - Early Interv Psychiatry VL - 10 IS - 5 N2 - AIM: It has been found that long-chain omega-3 polyunsaturated fatty acids (PUFAs) reduce the risk of progression to first episode of psychosis (FEP) and may offer a safe and efficacious strategy for selective and indicated prevention in young people with ultra-high-risk (UHR) states. An opportunity for exploring the trajectory of FEP and for investigating the efficacy of preventive treatments exists in 22q11.2 deletion syndrome (22q11DS), which has a 30% psychotic transition rate. The fact that 22q11DS patients are more homogeneous than other UHR groups and are characterized by high level of negative symptoms provides a strong rationale for the use of PUFAs. The principal aim of the present trial is to investigate the effects of PUFAs in individuals with 22q11DS who are at UHR for developing FEP. METHODS: A prospective, randomized, double-blind, placebo-controlled, single-centre study design will be used. Eighty individuals aged 12-26 will be randomly assigned to two treatment conditions. RESULTS: The experimental group will receive PUFAs. The placebo group will receive paraffin oil. Standard clinical assessments and neuropsychological tests will be performed at baseline and at 8-, 12-, 26- and 52-week follow-up. Blood samples will be collected at baseline and after 12 weeks. This study is registered as an International Standard RCT, number 02070211. The corresponding author is supported by a NARSAD Young Investigator Award. CONCLUSIONS: This is the protocol of a planned study that aims to test the efficacy of PUFAs in the prodromal phase of FEP, in a specific syndrome where there is strong evidence that a high genetic load is involved in the disorder. SN - 1751-7893 UR - https://www.unboundmedicine.com/medline/citation/25345540/Indicated_prevention_with_long_chain_polyunsaturated_omega_3_fatty_acids_in_patients_with_22q11DS_genetically_at_high_risk_for_psychosis__Protocol_of_a_randomized_double_blind_placebo_controlled_treatment_trial_ L2 - https://doi.org/10.1111/eip.12197 DB - PRIME DP - Unbound Medicine ER -