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Treatment of Anxiety and Anorexia Nervosa in Adolescents (TAANA)

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ClinicalTrials.gov Identifier: NCT01933243
Recruitment Status : Completed
First Posted : September 2, 2013
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Andrea Bonny, Nationwide Children's Hospital

August 9, 2013
September 2, 2013
October 11, 2017
April 23, 2018
April 23, 2018
August 2013
December 2016   (Final data collection date for primary outcome measure)
Medication Side Effects Score [ Time Frame: 6 and12 weeks ]
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.
Tolerability of fish oil supplementation in adolescents with anorexia nervosa. [ Time Frame: 12 weeks ]
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.
Complete list of historical versions of study NCT01933243 on ClinicalTrials.gov Archive Site
Beck Anxiety Inventory—Trait (BAIT) [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
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.
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 ]
Change in BAIT scores between weeks 0, 8, and 12
Number of Participant Tolerating Saliva Collection and 24 Hour Heart Rate Monitor Use [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
At baseline, 6 weeks, and 12 weeks, study participants were asked to collect salivary samples 5 times over a 24 hour period. In addition, participants were asked to wear a 24 hour heart monitor during this same 24 hour interval. Compliance wtth completion of these physiological measures was assessed as follows:
  1. For saliva collection, compliance was assessed by return of 5 full vials of saliva with record of time collected.
  2. For 24 hour heart rate monitor, compliance was assessed by return of monitor with then downloading of data to confirm that the participant wore the device during the specified time interval.
  • 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 ]
    Compliance with saliva collection protocol.
  • Feasibility of incorporating massage therapy into the outpatient treatment of adolescents with anorexia nervosa. [ Time Frame: 4 weeks ]
    Feasibility of massage therapy will be assessed by appointment compliance (total attended/total scheduled x 100).
 
Treatment of Anxiety and Anorexia Nervosa in Adolescents
Treatment of Anxiety and Anorexia Nervosa in Adolescents
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Anxiety
  • Anorexia Nervosa
  • Drug: Fish oil
    Participants will take 4 capsules daily
    Other Names:
    • ProEPA Xtra soft gel capsules
    • Eicosapentaenoic acid (2120mg)/ docosahexaenoic acid (600mg)
  • Drug: Placebo pill
    Participants will take 4 capsules daily
    Other Name: soybean oil placebo capsules
  • Experimental: Fish oil
    Fish oil for 12 weeks
    Intervention: Drug: Fish oil
  • Placebo Comparator: Placebo pill
    Placebo pills for 12 weeks
    Intervention: Drug: Placebo pill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
40
December 2016
December 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Years to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01933243
TAANA-287112
No
Not Provided
Plan to Share IPD: No
Andrea Bonny, Nationwide Children's Hospital
Andrea Bonny
Not Provided
Principal Investigator: Andrea Bonny, MD Nationwide Children's Hospital
Nationwide Children's Hospital
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP