NAPLS Omega-3 Fatty Acid Versus Placebo Study

NCT01429454 | Completed Phase 1 Results DMC

• 2 other identifiers: NAPLS- Omega3U01MH081944
• Study Type: interventional
• Target: 127
• Locations: 2 countries
• Sites: 9

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).

Conditions

Psychosis

Keywords

Prodromal; Schizophrenia; Psychosis; Omega

Outcome Measures

Primary Outcomes (1)

• Rate of Conversion to Psychosis.

  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.The Structured Interview for Prodromal Syndromes (SIPS) include the "Presence of Psychotic Syndrome (POPS)" scale that determines if the criteria for conversion to psychosis are met. The scale is binary, a 1 equals conversion and 0 equals non-conversion.

  12 months

Secondary Outcomes (1)

• Scale of Prodromal Symptoms (SOPS) Total Score (Indexing Severity of Positive, Negative, and General Symptoms)

  6 month follow up

Study Arms (2)

Soybean-Corn Blend Capsule

PLACEBO COMPARATOR

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

Omega 3 long chain fatty acid

EXPERIMENTAL

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

Interventions

Omega-3 Long Chain Fatty Acid DRUG

: 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.

Also known as: Fish Oil, Ocean Nutrition

Omega 3 long chain fatty acid

Placebo DRUG

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.

Soybean-Corn Blend Capsule

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (9)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, San Diego

San Diego, California, 92093, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Harvard

Boston, Massachusetts, 02215, United States

Location

Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15206, United States

Location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oils; Lipids

Limitations and Caveats

The high rate of attrition was a limitation in being able to fully assess the psychotic conversion outcome of this study or outcome greater than 6 months.

Results Point of Contact

• Title: Dr. Kristin Cadenhead
• Organization: University of California San Diego

kcadenhead@ucsd.edu

(619) 543-6445

Study Officials

• Kristin S Cadenhead, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2011
• First Posted: September 7, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 25, 2021
• Results First Posted: May 19, 2020

Record last verified: 2021-02

Locations

US (8); CA (1)