NAPLS Omega-3 Fatty Acid Versus Placebo Study
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, San Diego
Collaborator:
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: May 2, 2014
Last verified: October 2013
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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:
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 2014 |
| Primary Completion Date: | May 2014 (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.
Other Name: Placebo
|
|
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 |
| 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
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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
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
Investigators
| Principal Investigator: | Kristin S Cadenhead, MD | UCSD |
More Information
No publications provided
| 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: | May 2, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of California, San Diego:
|
Prodromal Schizophrenia Psychosis Omega |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on February 25, 2015