Treatment of Anxiety and Anorexia Nervosa in Adolescents
Condition: Anxiety; Anorexia Nervosa
MeSH terms: Anorexia; Anxiety Disorders; Anorexia Nervosa
Study type: Interventional
Phase: Phase 2

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 nervosa.
    

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.
    

Intervention name(s): Fish oil; Placebo pill
Intervention type(s): Drug; Drug
Intervention description(s): Participants will take 4 capsules daily; Participants will take 4 capsules daily
Other intervention name(s): ProEPA Xtra soft gel capsules; Eicosapentaenoic acid (2120mg)/ docosahexaenoic acid (600mg); soybean oil placebo capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anxiety; Anorexia nervosa; Adolescents; Fish oil