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| ID | Type | Description | Link |
|---|---|---|---|
| 22/2011 | Other Identifier | Institute of Psychiatry and Neurology Warsaw |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo ,anorexia nervosa | Placebo Comparator | 2x3 placebo capsules with olive oil | |
| fatty acids preparation- eye-q | Experimental | 2 x 3 tablets of eye -q preparation daily ( 558 mg of EPA, 175 mg of DHA, 60 mg fo GLA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fatty acids preparation- eye-q | Dietary Supplement | 3x2 tablets daily by 70 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| changes in CGI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agnieszka Piróg-Balcerzak, MD | Contact | 48606431574 | askapb@wp.pl |
| Name | Affiliation | Role |
|---|---|---|
| Agnieszka Piróg-Balcerzak, MD | Institute of Psychiatry and Neurology, Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Psychiatry and Neurology, | Recruiting | Warsaw | Masovian Voivodeship | 02-957 | Poland |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 5, 2016 | |
| Reset | Feb 5, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 5, 2016 | Feb 5, 2016 |
| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |