Anorexia Nervosa
Conditions
Keywords
omega-3 fatty acids, anorexia nervosa, efficacy, safety
Brief 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.
Interventions
DIETARY_SUPPLEMENTfatty acids preparation- eye-q
3x2 tablets daily by 70 days
Sponsors
Institute of Psychiatry and Neurology, Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 19 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Omega-3 fatty acids are superior to placebo in increasing BMI at day 70 compared with baseline | day 70th | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in CGI | day 70th | to compare the effects of fatty acids with the effect of placebo by change from baseline to day 70 in CGI (Clinical Global Impression) |
| change in HDRS | day 70 th | to compare the effects of fatty acids with the effect of placebo on change form baseline to day 70 in Hamilton Depression Rating Scale |
| changes in BDI | day 70th | to compare the effects of fatty acids with the effect of placebo by change form baseline to day 70 in Beck Depression Inventory |
| reducing EAT -26 | day 70th | 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 |
| adverse events | 70 days time | 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 |
| clinical laboratory tests | day 70 th | 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) |
| changes in YBOCS | day 70 th | to compare the effects of fatty acids with the effect of placebo by changes in Yale-Brown Obsessive-Compulsive Scale |
Countries
Poland
Contacts
Primary ContactAgnieszka Piróg-Balcerzak, MD
Outcome results
None listed