CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
Smoothie 1g Eicosapentaneoic Acid (EPA) and 1g Docoshaexanoic Acid (DHA)dietary
Likely dose
Smoothie 1g Eicosapentaneoic Acid (EPA) and 1g Docoshaexanoic Acid (DHA)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04210804
NCT04210804Phase 2Completed
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A Prophylactic Trial of Omega-3 Polyunsaturated Fatty Acids in Bipolar Disorder

National University of Ireland, Galway, Ireland·interventional·Posted Dec 26, 2019·Updated Dec 26, 2019

In Brief

A Phase 2 clinical trial evaluating Smoothie 1g Eicosapentaneoic Acid (EPA) and 1g Docoshaexanoic Acid (DHA) for Bipolar Depression. Completed, enrolled 80 participants across 1 site.

Detailed Summary

This study is a 52 week double-blind placebo controlled study of omega-3 polyunsaturated fatty acids (PUFAs) in bipolar disorder (who have a history of 3 or more episodes) to ascertain if omega-3 PUFAs reduce the risk of further relapse for both / either depressive or (hypo)manic episodes. This is a single-centre, 52 week, double-blind, randomised comparison of omega-3 PUFA (1g EPA and 1g DHA) versus placebo as adjunctive treatment in individuals with bipolar disorder

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Depression
CountriesIreland
CollaboratorsStanley Medical Research Institute

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 26, 2019
Enrollment StartApr 1, 2014
Primary CompletionOct 1, 2017
Study CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 6.5 years ago

Interventions

Smoothie 1g Eicosapentaneoic Acid (EPA) and 1g Docoshaexanoic Acid (DHA)dietary

200mls Smoothie