Phase 1
N=127
NAPLS Omega-3 Fatty Acid Versus Placebo Study
Psychosis
Bottom Line
View on ClinicalTrials.gov: NCT01429454 ↗Enrolled (actual)
127
Serious AEs
4.7%
Results posted
May 2020
Primary outcome: Primary: Rate of Conversion to Psychosis. — 4; 3 Participants — p=.51
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Omega-3 Long Chain Fatty Acid (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Conversion to Psychosis. |
4; 3 | .51 |
| SECONDARY Scale of Prodromal Symptoms (SOPS) Total Score (Indexing Severity of Positive, Negative, and General Symptoms) |
27.2; 28.8 | >0.10 |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01429454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.