NAPLS Omega-3 Fatty Acid Versus Placebo Study
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|ClinicalTrials.gov Identifier: NCT01429454|
Recruitment Status : Unknown
Verified November 2015 by Kristin Cadenhead, M.D., University of California, San Diego.
Recruitment status was: Active, not recruiting
First Posted : September 7, 2011
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Psychosis||Drug: Omega-3 Long Chain Fatty Acid Drug: Placebo||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429454
|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|
|New Haven, Connecticut, United States, 06519|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Massachusetts|
|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|
|University of Calgary|
|Calgary, Alberta, Canada, T2N 1N4|
|Principal Investigator:||Kristin S Cadenhead, MD||UCSD|