Anorexia NervosaPhase 2FASANNCT01761942
Fatty Acids Omega -3 Diet Supplementation Efficiency and Safety Evaluation in Anorexia Nervosa
A Phase 2 study testing fatty acids preparation- eye-q in people with Anorexia Nervosa, run by Institute of Psychiatry and Neurology, Warsaw at 1 site in Poland.
Trial summary
The purpose of this study is to determine whether omega -3 fatty acids are effective and safe in treating anorexia nervosa. Read more about this study
- Who is it for?
- Ages 12 to 19 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- fatty acids preparation- eye-q
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2012to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Anorexia nervosa (DSM IV,ICD-10)
- Female
- Age 12-19
- Written informed consent given by patient and his parents
Who cannot join
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Institute of Psychiatry and Neurology,
Warsaw, Masovian Voivodeship, 02-957
Agnieszka Piróg-Balcerzak, MD, 48-606-43-15-74, askapb@wp.pl
Agnieszka Piróg-Balcerzak, MD
About this study
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
The purpose of this study is to determine whether omega -3 fatty acids are effective and safe in treating anorexia nervosa.
Read the 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.
- Conditions
- Anorexia Nervosa
- Being tested
- fatty acids preparation- eye-q
- Keywords
- omega-3 fatty acids, anorexia nervosa, efficacy, safety
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fatty acids preparation- eye-qDietary supplement
3x2 tablets daily by 70 days
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: fatty acids preparation- eye-q |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: day 70th
Secondary outcomes (8)
reducing EAT -26
- 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: day 70 th
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Psychiatry and Neurology, Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Piróg-Balcerzak, Institute of Psychiatry and Neurology, Warsaw
- Investigators
- Agnieszka Piróg-Balcerzak, MD, Principal investigator, Institute of Psychiatry and Neurology, Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761942
- Sponsor's protocol ID
- 22/2011
- Other IDs
- 22/2011
- Acronym
- FASAN
- Status last verified
- Jan 2013
- First submitted
- 2 Jan 2013
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01761942
- Acronym / sponsor ID
- FASAN / 22/2011
- Conditions
- Anorexia Nervosa
- Keywords
- omega-3 fatty acids, anorexia nervosa, efficacy, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institute of Psychiatry and Neurology, WarsawUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo ,anorexia nervosa | Placebo comparator | –2x3 placebo capsules with olive oil |
| fatty acids preparation- eye-q | Experimental | Dietary Supplement: fatty acids preparation- eye-q2 x 3 tablets of eye -q preparation daily ( 558 mg of EPA, 175 mg of DHA, 60 mg fo GLA). |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Anorexia nervosa (DSM IV,ICD-10)
- Female
- Age 12-19
- Written informed consent given by patient and his parents
Key exclusion criteria (1 listed)
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fatty acids preparation- eye-q3x2 tablets daily by 70 days | Dietary supplement | fatty acids preparation- eye-q |
Primary outcome
Omega-3 fatty acids are superior to placebo in increasing BMI at day 70 compared with baseline
Time frame: 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)
8 secondary outcomes
reducing EAT -26
Time frame: day 70th
changes in CGI
Time frame: day 70th
change in HDRS
Time frame: day 70 th
changes in BDI
Time frame: day 70th
changes in YBOCS
Time frame: day 70 th
changes in YBOCS
Time frame: day 70th
adverse events
Time frame: 70 days time
clinical laboratory tests
Time frame: day 70 th
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnieszka Piróg-Balcerzak, MD principal investigator
Institute of Psychiatry and Neurology, Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fatty acids preparation- eye-q in people with Anorexia Nervosa, run by Institute of Psychiatry and Neurology, Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnieszka Piróg-Balcerzak, MD (48606431574, askapb@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Omega-3 fatty acids are superior to placebo in increasing BMI at day 70 compared with baseline (time frame: day 70th). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2013.