NCT02597439

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Rene Kahn · Academic / Other
• Sex: All
• Age: 13 Years – 20 Years
• Healthy volunteers: Accepted

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.

Detailed description

PURPOSE is a randomized double-blind placebo-controlled study. Main objective is to assess the effectivity of omega-3 fatty acid treatment in the prevention of psychosis. The primary outcome measure is the rate of transition to psychosis as determined through CAARMS. Subjects in the age range of 13-20 years with a higher chance of developing psychosis, as determined by the CAARMS, are treated for 6 months with omega-3 fatty acids or placebo. This study in conducted at 14 sites in 9 countries.

Conditions

• Ultra High Risk for Psychosis

Interventions

Type	Name	Description
DRUG	Omega-3 fatty acids
OTHER	Placebo

Timeline

• Start date: 2016-09-30
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2015-11-05
• Last updated: 2023-02-14

Locations

14 sites across 9 countries: Austria, Germany, Israel, Italy, Netherlands, Norway, Spain, Switzerland, United Kingdom