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AnxietyPhase 2TAANANCT01933243

Treatment of Anxiety and Anorexia Nervosa in Adolescents

A Phase 2 study testing Fish oil in people with Anxiety and Anorexia Nervosa, run by Andrea Bonny at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Adolescents with anorexia nervosa frequently have associated anxiety, and standard medications used for anxiety are unhelpful when patients are malnourished. This is a 12 week trial examining the safety, tolerability, and effectiveness of fish oil nutritional supplements for anxiety in adolescents with anorexia… Read more about this study

Who is it for?
Ages 12 to 21 years
Conditions the study is for
Anxiety, Anorexia Nervosa
What is being tested?
Fish oil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteUnited States
Study dates
Aug 2013to Dec 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Females admitted to Nationwide Children's Hospital Eating Disorder Partial Hospitalization Program

Who cannot join

  • Inability to take pills
  • Co-morbid medical conditions affecting appetite and weight (e.g., inflammatory bowel disease, cancer, cystic fibrosis)
  • Co-morbid psychiatric conditions affecting appetite and weight (e.g., bipolar disorder, substance abuse)
  • Currently taking fish oil supplements
  • Inability to participate in study for 12 consecutive weeks.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

Other trials in United States

About this study

Adolescents with anorexia nervosa frequently have associated anxiety, and standard medications used for anxiety are unhelpful when patients are malnourished. This is a 12 week trial examining the safety, tolerability, and effectiveness of fish oil nutritional supplements for anxiety in adolescents with anorexia nervosa.

Read the detailed description

Anorexia nervosa (AN) is an eating disorder characterized by a morbid fear of weight gain and a perception of being overweight despite objective evidence of weight loss and malnutrition. It has been estimated that almost 0.9% of women will suffer from AN at some point in their lives, and most cases of AN arise during adolescence. Even with appropriate treatment, only about half of patients with AN will have a full recovery, 30% partial recovery, and 20% will progress to having a chronic illness. Earlier, more aggressive treatment with appropriate nutritional recovery during adolescence offers the best chance of a full recovery. Treatment of AN is complicated by the high rate of comorbid psychiatric diagnoses, the physical and cognitive effects of the attendant malnutrition, and the lack of effective pharmacologic interventions. Approximately 75% of patients with AN have a comorbid psychiatric illness, including depression, obsessive compulsive disorder, and anxiety. Anxiety disorders in particular share attributes with AN, including perfectionism, rigidity, compulsivity, and harm avoidance in addition to trait anxiety. Complicating treatment, the risk and severity of patients' anxiety is enhanced by a lower body mass index (BMI), and this low BMI is the likely reason why standard medication treatments for generalized anxiety, such as selective serotonin reuptake inhibitors are ineffective. In order to address these treatment challenges, we propose to study the tolerability, feasibility and efficacy of a non-pharmacologic interventions for anxiety in adolescents with AN: omega-3 polyunsaturated fatty acid (PUFA) supplementation.

Over the past 15 years, there has been an interest in possible associations between fish oil and affective illness, particularly depression. Low plasma levels of docosahexaenoic acid, an essential fatty acid found in fish oil, are associated with low concentrations of cerebrospinal fluid 5-hydroxyindolacetic acid (5-HIAA), a marker of central nervous system serotonin turnover. Epidemiologically, those populations with higher fish oil consumption tend to have lower rates of depression, and reported low levels of fish consumption have been associated with a greater risk of depression in women. It has been hypothesized that omega-3 PUFAs alter brain phospholipid composition and enhance membrane fluidity, and this is supported by evidence that supplementation with omega-3 PUFAs decreases brain water proton transverse relaxation times in patients with bipolar disorder. The association with depression and the proposed mechanism of action elicited some interest regarding associations between omega-3 PUFAs and anxiety disorders. Supplementation trials have shown mixed results, with no effects for obsessive compulsive disorder in patients taking maximum doses of selective serotonin reuptake inhibitors, and another showing decreased anxiety symptoms in 22 patients enrolled in a substance abuse treatment program. Recently, Kiecolt-Glaser and colleagues described a decrease in test-related anxiety symptoms in a non-clinical sample of medical students related to supplementation with omega-3 PUFAs. Although there has been some interest in the use of omega-3 PUFA supplementation as an adjunctive treatment for anorexia nervosa, there have been no systematic trials.

Being tested
Fish oil, Placebo pill
Keywords
Anxiety, Anorexia nervosa, Adolescents, Fish oil
Medical subject headings
Anxiety Disorders, Anorexia Nervosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fish oilDrug

    Also called ProEPA Xtra soft gel capsules, Eicosapentaenoic acid (2120mg)/ docosahexaenoic acid (600mg)

    Participants will take 4 capsules daily

  • Placebo pillDrug

    Also called soybean oil placebo capsules

    Participants will take 4 capsules daily

Study groups in NCT01933243
Study groupRoleWhat they receive
Fish oilExperimentalFish oil for 12 weeks
Receives: Drug: Fish oil
Placebo pillPlacebo comparatorPlacebo pills for 12 weeks
Receives: Drug: Placebo pill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medication Side Effects Score

    At 6 and 12 weeks, medication tolerability was assessed via self-report of nine potential side effects (e.g. diarrhea, burping). Participants were asked whether they experienced these side effects "never, rarely, occasionally, frequently, or very frequently." Individual responses were assigned a numeric equivalent from 0 to 4, and summed for a total side effect score ranging from 0 to 36. Higher scores indicated greater frequency of side effects and lower medication tolerability.

    Measured: 6 and12 weeks

Secondary outcomes (1)
  1. Beck Anxiety Inventory-Trait (BAIT)

    The BAIT is a 21-item self-report measure of anxiety severity rated on a 4-point Likert scale (0= rarely or never; 3= almost always). It has shown acceptable reliability and validity in an adolescent psychiatric inpatient population. BAIT scores over 26 indicate severe anxiety, scores 16-25 indicate moderate anxiety, scores 8-15 indicate mild anxiety, and scores 0-7 indicate a minimal level of anxiety. We chose to measure trait anxiety to examine beyond meal-related (state) anxiety.

    Measured: Baseline, 6 weeks, and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01933243
Sponsor's protocol ID
TAANA-287112
Acronym
TAANA
Status last verified
Mar 2018
First submitted
9 Aug 2013
Last updated
23 Apr 2018
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fish oil in people with Anxiety and Anorexia Nervosa, run by Andrea Bonny at 1 site in United States.

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 1 inclusion and 5 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: finished, as of the sponsor's last update on 23 Apr 2018. 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 United States. 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?

Yes. Results are posted in the registry (first posted 23 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medication Side Effects Score (time frame: 6 and12 weeks). 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 23 Apr 2018.

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