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NCT01429454 · ClinicalTrials.gov registry record · Phase 1
NAPLS Omega-3 Fatty Acid Versus Placebo Study
A Phase 1 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 1
- Development phase
- 127
- Enrollment target
NCT01429454: Completed Phase 1 study, sponsored by University of California, San Diego.
NCT01429454 is a Phase 1 study that has completed, run by University of California, San Diego. The registered enrollment target is 127 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01429454, a Phase 1 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 127 participants
- Enrollment target
Study 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).
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Omega-3 Long Chain Fatty Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2011-08 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT01429454 record still lists
NCT01429454 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01429454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01429454 about?
NCT01429454 is a clinical study titled "NAPLS Omega-3 Fatty Acid Versus Placebo Study". 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 det...
What is the current status of trial NCT01429454?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 127 participants. The study started on 2011-08. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01429454?
The interventions under investigation include: Placebo (DRUG), Omega-3 Long Chain Fatty Acid (DRUG).
Who is sponsoring clinical trial NCT01429454?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01429454's enrollment target sits among peer trials
127 459th of 2000 higher than 1,540 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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