A Phase 2 interventional study of fatty acids preparation- eye-q in Anorexia Nervosa, sponsored by Institute of Psychiatry and Neurology, Warsaw. Status unknown at 1 site in Poland. Open to female participants aged 12 Years to 19 Years. Per ClinicalTrials.gov, last updated 2013-01-07.
Sponsored by Institute of Psychiatry and Neurology, Warsaw · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether omega -3 fatty acids are effective and safe in treating anorexia nervosa.
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.
411 studies on the registry are indexed under Anorexia; 67 are open to participants now.
This study's planned enrollment of 60 is above the median of 41 across 287 interventional studies indexed under Anorexia.
Browse Anorexia studies →Institute of Psychiatry and Neurology, Warsaw is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2x3 placebo capsules with olive oil
2 x 3 tablets of eye -q preparation daily ( 558 mg of EPA, 175 mg of DHA, 60 mg fo GLA).
Dietary Supplement: fatty acids preparation- eye-q
3x2 tablets daily by 70 days
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)
Time frame: day 70th
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
Time frame: day 70th
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)
Time frame: day 70th
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
Time frame: day 70 th
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
Time frame: day 70th
changes in YBOCS
to compare the effects of fatty acids with the effect of placebo by changes in Yale-Brown Obsessive-Compulsive Scale
Time frame: day 70 th
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
Time frame: day 70th
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
Time frame: 70 days time
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)
Time frame: day 70 th
This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Institute of Psychiatry and Neurology, Warsaw