NAPLS Omega-3 Fatty Acid Versus Placebo Study

Study Description

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Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Psychosis	Drug: Omega-3 Long Chain Fatty Acid; Drug: Placebo	Phase 1

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	128 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Randomized Double-Blind Trial of Omega 3 Fatty Acid Versus Placebo in Individuals at Risk for Psychosis
Study Start Date :	August 2011
Estimated Primary Completion Date :	May 2016
Estimated Study Completion Date :	May 2016

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: Soybean-Corn Blend Capsule; The placebo is a soybean/corn blend. Both the Omega-3FA and placebo are colored with carob (so shell is brown) and flavored with natural lemon-lime, to mask them.	Drug: Placebo; The placebo is a soybean/corn blend. Both the Omega-3FA and placebo are colored with carob (so shell is brown) and flavored with natural lemon-lime, to mask them. The dose will be 2 capsules per day.
Experimental: Omega 3 long chain fatty acid; The Omega-3 Fatty Acid compound will be manufactured by Ocean Nutrition Canada and contain an 2:1 proportion of EPA to DHA in which each capsule includes 370 mg EPA and 200 mg DHA as well as 2 mg/g Tocopherol. The dose will be two capsules per day for a total of 740 mg of EPA and 400 mg of DHA.	Drug: Omega-3 Long Chain Fatty Acid; : The Omega-3FA compound will be manufactured by Ocean Nutrition Canada and contain an 2:1 proportion of EPA to DHA in which each capsule includes 370 mg EPA and 200 mg DHA as well as 2 mg/g Tocopherol. The dose will be two capsules per day for a total of 740 mg of EPA and 400 mg of DHA.; Other Name: Fish Oil, Ocean Nutrition

Outcome Measures

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Primary Outcome Measures :

1. rate of conversion to psychosis [ Time Frame: 12 months ]
   The rate of conversion to psychosis among prodromal patients assigned at random to Omega-3 Fatty Acids at 12 months will be significantly lower than that among patients assigned to placebo.

Secondary Outcome Measures :

1. Scale of Prodromal Symptoms (SOPS) total score (indexing severity of positive, negative, and general symptoms) [ Time Frame: 6 months and 12 months ]
   The reduction from baseline in the Scale of Prodromal Symptoms (SOPS) total score (indexing severity of positive, negative, and general symptoms) at 6 and 12 months will be significantly greater in prodromal patients assigned at random to Omega-3 Fatty Acids than in patients assigned to placebo.

Eligibility Criteria

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Ages Eligible for Study:	12 Years to 30 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Contacts and Locations

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Locations

United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
University of California, San Diego
San Diego, California, United States, 92093
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Harvard
Boston, Massachusetts, United States, 02215
United States, New York
Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15206
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 1N4

Sponsors and Collaborators

University of California, San Diego

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Kristin S Cadenhead, MD	UCSD

More Information

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Responsible Party:	Kristin Cadenhead, M.D., Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier:	NCT01429454 History of Changes
Other Study ID Numbers:	NAPLS- Omega3; U01MH081944 ( U.S. NIH Grant/Contract )
First Posted:	September 7, 2011
Last Update Posted:	December 2, 2015
Last Verified:	November 2015

Keywords provided by Kristin Cadenhead, M.D., University of California, San Diego:

Prodromal; Schizophrenia; Psychosis; Omega

Additional relevant MeSH terms:

Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders