Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe

Phase 4 Completed 145 enrolled Rene Kahn

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to determine whether omega-3 fatty acids are effective in the prevention of psychosis in individuals at ultra-high risk for psychosis.

Timeline

Start: 2016-09-30
Primary completion: 2023-02-01
Completion: 2023-02-01

Publications

Winter-van Rossum I, Slot MIE, van Hell HH, Bossong MG, Berger G, Aschauer H, Maat A, Walitza S, Lavan O, Baeza I, Dolz M, Monducci E, Fiori Nastro P, Kroken RA, Lawrie SM, Diaz-Caneja CM, Renner T, Schlogelhofer M, Scharinger C, Spalletta G, Banaj N, Otero S, Schipper M, Kwakkel DB; PURPOSE Study Group; Kahn RS. Effectiveness of Omega-3 Fatty Acids Versus Placebo in Subjects at Ultra-High Risk for Psychosis: The PURPOSE Randomized Clinical Trial. Schizophr Bull. 2025 Jul 7;51(4):1082-1091. doi: 10.1093/schbul/sbae186.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Omega-3 fatty acids	Unknown	1.2 g	—

Indications

No indication recorded.