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

Anorexia Nervosa Clinical Trial

— FASAN  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01761942
• Other study ID #: 22/2011
• Secondary ID: 22/2011
• Status: Unknown status
• Phase: Phase 2
• First received: January 2, 2013
• Last updated: January 3, 2013
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2013
• Source: Institute of Psychiatry and Neurology, Warsaw
• Contact: Agnieszka Piróg-Balcerzak, MD
• Phone: 48606431574
• Email: askapb[@]wp.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 19 Years

Eligibility

Inclusion Criteria:

• Anorexia nervosa (DSM IV,ICD-10)

• Female

• Age 12-19

• Written informed consent given by patient and his parents

Exclusion Criteria:

• Lack of informed consent

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Dietary Supplement:
• fatty acids preparation- eye-q
3x2 tablets daily by 70 days

Locations

Country	Name	City	State
Poland	Institute of Psychiatry and Neurology,	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Psychiatry and Neurology, Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Omega-3 fatty acids are superior to placebo in increasing BMI at day 70 compared with baseline	The primary objective of this study is to compare the efficacy of EPA fatty acids with that of placebo as add-on treatment for inpatients with anorexia nervosa, as assessed by the change from baseline to day 70 in BMI (body mass index)	day 70th
Secondary	reducing EAT -26	1. To compare the effects of omega-3/6 fatty acids with the effect of placebo in reducing EAT-26 (Eating Attitude Test-26) total score at day 70 compared with baseline	day 70th
Secondary	changes in CGI	to compare the effects of fatty acids with the effect of placebo by change from baseline to day 70 in CGI (Clinical Global Impression)	day 70th
Secondary	change in HDRS	to compare the effects of fatty acids with the effect of placebo on change form baseline to day 70 in Hamilton Depression Rating Scale	day 70 th
Secondary	changes in BDI	to compare the effects of fatty acids with the effect of placebo by change form baseline to day 70 in Beck Depression Inventory	day 70th
Secondary	changes in YBOCS	to compare the effects of fatty acids with the effect of placebo by changes in Yale-Brown Obsessive-Compulsive Scale	day 70 th
Secondary	changes in YBOCS	to compare the effects of fatty acids with the effect of placebo by change form baseline to day 70 Yale-Brown Obsessive-Compulsive Scale	day 70th
Secondary	adverse events	to evaluate the safety and tolerability of omega-3 fatty acids compared with placebo in the treatment of anorexia nervosa, as assessed by incidence and nature of adverse events	70 days time
Secondary	clinical laboratory tests	to evaluate the safety and tolerability of omega-3 fatty acids compared with placebo in the treatment of anorexia nervosa, as assessed by changes from baseline to day 70 in clinical laboratory tests (lipids metabolism - triglycerides, HDL and LDL cholesterol)	day 70 th