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NAPLS Omega-3 Fatty Acid Versus Placebo Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Kristin Cadenhead, M.D., University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01429454
First received: August 29, 2011
Last updated: November 30, 2015
Last verified: November 2015
History of Changes
  Purpose
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 Intervention Phase
Psychosis
 Drug: Omega-3 Long Chain Fatty Acid
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • rate of conversion to psychosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Scale of Prodromal Symptoms (SOPS) total score (indexing severity of positive, negative, and general symptoms) [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    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.
Estimated Enrollment: 128
Study Start Date: August 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility
Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429454

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

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 
Study First Received: August 29, 2011
Last Updated: November 30, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Diego:
Prodromal
Schizophrenia
Psychosis
Omega

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders

ClinicalTrials.gov processed this record on September 28, 2016