Trial record 16 of 302 for:    Open Studies | "Fatty Acids"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Institute of Psychiatry and Neurology, Warsaw
Sponsor:
Information provided by (Responsible Party):
Agnieszka Piróg-Balcerzak, Institute of Psychiatry and Neurology, Warsaw
ClinicalTrials.gov Identifier:
NCT01761942
First received: January 2, 2013
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Anorexia Nervosa
Dietary Supplement: fatty acids preparation- eye-q
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Institute of Psychiatry and Neurology, Warsaw:

Primary Outcome Measures:
  • Omega-3 fatty acids are superior to placebo in increasing BMI at day 70 compared with baseline [ Time Frame: day 70th ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • reducing EAT -26 [ Time Frame: day 70th ] [ Designated as safety issue: No ]
    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

  • changes in CGI [ Time Frame: day 70th ] [ Designated as safety issue: No ]
    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 [ Time Frame: day 70 th ] [ Designated as safety issue: No ]
    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 [ Time Frame: day 70th ] [ Designated as safety issue: No ]
    to compare the effects of fatty acids with the effect of placebo by change form baseline to day 70 in Beck Depression Inventory

  • changes in YBOCS [ Time Frame: day 70 th ] [ Designated as safety issue: No ]
    to compare the effects of fatty acids with the effect of placebo by changes in Yale-Brown Obsessive-Compulsive Scale

  • changes in YBOCS [ Time Frame: day 70th ] [ Designated as safety issue: No ]
    to compare the effects of fatty acids with the effect of placebo by change form baseline to day 70 Yale-Brown Obsessive-Compulsive Scale

  • adverse events [ Time Frame: 70 days time ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: day 70 th ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo ,anorexia nervosa
2x3 placebo capsules with olive oil
Experimental: fatty acids preparation- eye-q
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

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.

  Eligibility

Ages Eligible for Study:   12 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761942

Contacts
Contact: Agnieszka Piróg-Balcerzak, MD 48606431574 askapb@wp.pl

Locations
Poland
Institute of Psychiatry and Neurology, Recruiting
Warsaw, Mazowieckie, Poland, 02-957
Contact: Agnieszka Piróg-Balcerzak, MD    48-606-43-15-74    askapb@wp.pl   
Principal Investigator: Agnieszka Piróg-Balcerzak, MD         
Sponsors and Collaborators
Institute of Psychiatry and Neurology, Warsaw
Investigators
Principal Investigator: Agnieszka Piróg-Balcerzak, MD Institute of Psychiatry and Neurology, Warsaw
  More Information

No publications provided

Responsible Party: Agnieszka Piróg-Balcerzak, MD, psychiatrist, Institute of Psychiatry and Neurology, Warsaw
ClinicalTrials.gov Identifier: NCT01761942     History of Changes
Other Study ID Numbers: 22/2011, 22/2011
Study First Received: January 2, 2013
Last Updated: January 3, 2013
Health Authority: Poland: Ethics Committee

Keywords provided by Institute of Psychiatry and Neurology, Warsaw:
omega-3 fatty acids
anorexia nervosa
efficacy
safety

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014