NCT01761942

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 7, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 7, 2013

Status Verified

January 1, 2013

Enrollment Period

2.2 years

First QC Date

January 2, 2013

Last Update Submit

January 3, 2013

Conditions

Anorexia Nervosa

Keywords

omega-3 fatty acidsanorexia nervosaefficacysafety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • reducing EAT -26

    day 70th

  • changes in CGI

    day 70th

  • change in HDRS

    day 70 th

  • changes in BDI

    day 70th

  • changes in YBOCS

    day 70 th

  • +3 more secondary outcomes

Study Arms (2)

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).

Dietary Supplement: fatty acids preparation- eye-q

Interventions

fatty acids preparation- eye-qDIETARY_SUPPLEMENT

3x2 tablets daily by 70 days

fatty acids preparation- eye-q

Eligibility Criteria

Age12 Years - 19 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Anorexia nervosa (DSM IV,ICD-10)
  • Female
  • Age 12-19
  • Written informed consent given by patient and his parents

You may not qualify if:

  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Psychiatry and Neurology,

Warsaw, Masovian Voivodeship, 02-957, Poland

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Agnieszka Piróg-Balcerzak, MD

    Institute of Psychiatry and Neurology, Warsaw

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnieszka Piróg-Balcerzak, MD

CONTACT

48606431574askapb@wp.pl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, psychiatrist

Study Record Dates

First Submitted

January 2, 2013

First Posted

January 7, 2013

Study Start

September 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 7, 2013

Record last verified: 2013-01

Locations

PL(1)