NAPLS Omega-3 Fatty Acid Versus Placebo Study

Completed · Phase 1 · Has a placebo group

Conditions studied: Psychosis

In brief

The overall goal of the present study is to determine whether Omega-3 Fatty Acids potentially prevent onset of psychosis and improve clinical symptoms and functional outcome in youth and young adults at elevated clinical risk for schizophrenia and related disorders. The specific aims are: (1) To determine whether the rate of progression to psychosis is lower during six months of treatment with Omega-3 Fatty Acids compared to six months of treatment with placebo, (2) To determine whether Omega-3 Fatty Acids are more efficacious than placebo for prodromal symptoms, negative symptoms, and functioning, (3) To assess the safety and tolerability of Omega-3 Fatty Acids in this population, and (4) To conduct analyses of neuroimaging, neurocognitive, electrophysiological and other ancillary data to explore mechanistic explanations for the hypothesized benefits of Omega-3 Fatty Acids on clinical and functional outcomes (e.g., increases in white matter integrity and processing speed).

Key facts

Study ID

NCT01429454

Run by

University of California, San Diego

People needed

127

Starts

2011-08-01

Expected to finish

2016-06-01

Last updated by the study team

2021-02-25

Who can join

Age: 12 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects will be included if they are treatment-seeking patients between the ages of 12 and 30 who meet diagnostic criteria for a possible prodromal syndrome and are part of the ongoing NAPLS study.

You may not qualify if…

• use of antipsychotic medication in the previous month.
• concomitant medical or neurological illness.
• history of significant head injury.
• alcohol or drug abuse (excluding nicotine) in the past month or dependence in the past three months.
• screening full scale estimated IQ < 80.
• active suicidal or homicidal ideation.
• pregnancy or lactation.
• allergies to seafood or seafood related products or no history of seafood consumption

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• University of California, San Diego — San Diego, California, United States
• Yale University — New Haven, Connecticut, United States
• Emory University — Atlanta, Georgia, United States
• Harvard — Boston, Massachusetts, United States
• Zucker Hillside Hospital — Glen Oaks, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• VA Pittsburgh Healthcare System — Pittsburgh, Pennsylvania, United States
• University of Calgary — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

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