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Columbus, Ohio 43205

  • Anorexia Nervosa

Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: Females admitted to Nationwide Children's Hospital Eating Disorder Partial Hospitalization Program Exclusion Criteria: 1. Inability to take pills 2. Co-morbid medical conditions affecting appetite and weight (e.g., inflammatory bowel disease, cancer, cystic fibrosis) 3. Co-morbid psychiatric conditions affecting appetite and weight (e.g., bipolar disorder, substance abuse) 4. Currently taking fish oil supplements 5. Inability to participate in study for 12 consecutive weeks.


Study is Available At:


Original ID:

TAANA-287112


NCT ID:

NCT01933243


Secondary ID:


Study Acronym:

TAANA


Brief Title:

Treatment of Anxiety and Anorexia Nervosa in Adolescents


Official Title:

Treatment of Anxiety and Anorexia Nervosa in Adolescents


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

12 Years


Maximum Age:

21 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Nationwide Children's Hospital


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

24


Enrollment Type:

Actual


Overall Contact Information

Official Name:Andrea Bonny, MD
Principal Investigator
Nationwide Children's Hospital

Study Dates

Start Date:August 2013
Completion Date:December 2016
Completion Type:Actual
Primary Completion Date:December 2016
Primary Completion Type:Actual
Verification Date:March 2018
Last Changed Date:March 23, 2018
First Received Date:August 9, 2013
First Results Date:October 11, 2017

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Beck Anxiety Inventory—Trait (BAIT)
Time Frame:Baseline, 6 weeks, and 12 weeks
Safety Issues:False
Description: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 i
Outcome Type:Primary Outcome
Measure:Medication Side Effects Score
Time Frame:6 and12 weeks
Safety Issues:False
Description: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 frequent

Study Interventions

Intervention Type:Drug
Name:Fish oil
Description:Participants will take 4 capsules daily
Arm Name:Fish oil
Other Name:ProEPA Xtra soft gel capsules
Intervention Type:Drug
Name:Placebo pill
Description:Participants will take 4 capsules daily
Arm Name:Placebo pill
Other Name:soybean oil placebo capsules

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo pill
Description:Placebo pills for 12 weeks
Study Arm Type:Experimental
Arm Name:Fish oil
Description:Fish oil for 12 weeks

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Andrea Bonny

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 26, 2020

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