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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 is a Phase 1 study that has completed, run by University of California, San Diego. The registered enrollment target is 127 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01429454
The ClinicalTrials.gov registry entry for NCT01429454 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01429454 reports 0 study locations.
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.
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