NAPLS Omega-3 Fatty Acid Versus Placebo Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01429454|
Recruitment Status : Completed
First Posted : September 7, 2011
Results First Posted : May 19, 2020
Last Update Posted : February 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Psychosis||Drug: Omega-3 Long Chain Fatty Acid Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||127 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|
|Actual Study Start Date :||August 2011|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 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.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.
- Scale of Prodromal Symptoms (SOPS) Total Score (Indexing Severity of Positive, Negative, and General Symptoms) [ Time Frame: 6 month follow up ]
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.
Minimum SOPS score= 0 Maximum SOPS score= 114
Higher Total SOPS score does not necessarily mean the subject is more "psychotic" as the aggregate score is that of four independent categorically defined symptom subscales, including: Positive Symptoms Scale, Negative Symptoms Scale, Disorganized Symptoms Scale, and General Symptoms Scale. However, a higher Total SOPS score would likely indicate an individual is presenting with more overall symptoms.The Structured Interview for Prodromal Syndromes (SIPS) determines if the criteria for conversion to psychosis has been met.
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|