Treatment of Anxiety and Anorexia Nervosa in Adolescents (TAANA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Nationwide Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01933243
First received: August 9, 2013
Last updated: March 18, 2015
Last verified: March 2015
  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.


Condition Intervention Phase
Anxiety
Anorexia Nervosa
Drug: Fish oil
Drug: Placebo pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Anxiety and Anorexia Nervosa in Adolescents

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Tolerability of fish oil supplementation in adolescents with eating disorders. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Mean score on the 8-item fish oil tolerability scale, in addition to descriptive statistics of reported side effects and frequencies, will be used to assess tolerability of omega-3 fatty acid supplementation.


Secondary Outcome Measures:
  • Improvement in trait anxiety in subjects receiving a combination of omega-3 PUFA supplementation and massage therapy plus standard of careas compared to subjects receiving standard of care treatment alone (controls). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in BAIT scores between weeks 0, 8, and 12


Other Outcome Measures:
  • Feasibility of physiologic measures of anxiety (salivary α-amylase, salivary cortisol, high frequency heart rate variability) to assess anxiety and the trajectory of stress responses over time in adolescents with anorexia nervosa. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Compliance with saliva collection protocol.


Estimated Enrollment: 40
Study Start Date: August 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fish oil
Fish oil for 12 weeks
Drug: Fish oil
Participants will take 2 capsules daily
Other Names:
  • ProEPA Xtra soft gel capsules
  • Eicosapentaenoic acid (2120mg)/ docosahexaenoic acid (600mg)
Placebo Comparator: Placebo pill
Placebo pills for 12 weeks
Drug: Placebo pill
Participants will take 2 capsules daily

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 docosaheaenoic 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.

  Eligibility

Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01933243

Contacts
Contact: Andrea Bonny, MD 614-722-2642 andrea.bonny@nationwidechildrens.org
Contact: Brittny Manos, BA (614) 722-3502 brittny.manos@nationwidechildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Andrea Bonny, MD    614-722-2642    andrea.bonny@nationwidechildrens.org   
Principal Investigator: Andrea Bonny, MD         
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Andrea Bonny, MD Nationwide Children's Hospital
  More Information

No publications provided

Responsible Party: Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01933243     History of Changes
Other Study ID Numbers: TAANA-287112
Study First Received: August 9, 2013
Last Updated: March 18, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Nationwide Children's Hospital:
Anxiety
Anorexia nervosa
Adolescents
Fish oil

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

ClinicalTrials.gov processed this record on August 30, 2015