NCT01761942

Fatty Acids Omega -3 Diet Supplementation Efficiency and Safety Evaluation in Anorexia Nervosa

A 10-week Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Omega-3 Fatty Acids Oral Capsules Compared With Placebo in the Treatment of Anorexia Nervosa

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Institute of Psychiatry and Neurology, Warsaw · Academic / Other
• Sex: Female
• Age: 12 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether omega -3 fatty acids are effective and safe in treating anorexia nervosa.

Detailed description

10-week, randomized, placebo-controlled, parallel-group study to compare the efficacy and safety of omega-3 fatty acids with placebo in the treatment of anorexia nervosa. Patients will be randomly assigned to blinded study treatment. Double-blind treatment will be preceded by a medication washout period of 1-28 days if necessary. Some patients may be taking anti-depressants or anti-psychotics, e.g. fluoxetine, prior to admission to the study. In such case the wash out period will depend on the medical treatment (dependent on the drug given) given prior to qualification to the study. Patient will be treated as inpatients during 10 weeks of the study. The study will recruit female inpatients with anorexia nervosa (aged 12 to 19 years), with DSM-IV and ICD-10 diagnosis of anorexia nervosa.BMI below 5 percentile and EAT-26 score \> 30 is required at both screening and randomization.

Conditions

• Anorexia Nervosa

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	fatty acids preparation- eye-q	3x2 tablets daily by 70 days

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-01-07
• Last updated: 2013-01-07

Locations

1 site across 1 country: Poland