Trial record 12 of 45 for:    Open Studies | "Anorexia Nervosa"

Treatment of Anxiety and Anorexia Nervosa in Adolescents (TAANA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 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: August 28, 2013
Last verified: August 2013
  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. In addition, investigators are studying the effectiveness of a 4 week trial of massage therapy in these patients.


Condition Intervention Phase
Anxiety
Anorexia Nervosa
Drug: Fish oil
Procedure: Massage therapy
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 anorexia nervosa. [ 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.

  • Feasibility of incorporating massage therapy into the outpatient treatment of adolescents with anorexia nervosa. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Feasibility of massage therapy will be assessed by appointment compliance (total attended/total scheduled x 100).


Estimated Enrollment: 40
Study Start Date: August 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fish oil, massage therapy
Fish oil for 12 weeks plus massage therapy for 4 weeks
Drug: Fish oil
Participants will take 2 capsules daily
Other Names:
  • ProEPA Xtra soft gel capsules
  • Eicosapentaenoic acid (2120mg)/ docosahexaenoic acid (600mg)
Procedure: Massage therapy
30 minutes of modified Swedish massage three times weekly for 4 weeks
Active Comparator: Fish oil, no massage therapy
Fish oil for 12 weeks but no massage therapy
Drug: Fish oil
Participants will take 2 capsules daily
Other Names:
  • ProEPA Xtra soft gel capsules
  • Eicosapentaenoic acid (2120mg)/ docosahexaenoic acid (600mg)
Active Comparator: Placebo pill, massage therapy
Placebo pills for 12 weeks plus massage therapy for 4 weeks
Procedure: Massage therapy
30 minutes of modified Swedish massage three times weekly for 4 weeks
Drug: Placebo pill
Participants will take 2 capsules daily
Placebo Comparator: Placebo pill, no massage therapy
Placebo pills for 12 weeks, no massage therapy
Drug: Placebo pill
Participants will take 2 capsules daily

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

Clinical diagnosis of AN BMI less than 10th percentile for age and gender.

Exclusion Criteria:

  1. Symptoms for greater than 1 year
  2. inability to take pills
  3. co-morbid medical conditions affecting appetite and weight (e.g., inflammatory bowel disease, cancer, cystic fibrosis)
  4. co-morbid psychiatric conditions affecting appetite and weight (e.g., bipolar disorder, substance abuse)
  5. current treatment with psychiatric medications, including selective serotonin reuptake inhibitors, benzodiazepines, and neuroleptic medications
  6. Currently taking fish oil supplements
  7. 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: Terrill Bravender, MD, MPH 614-722-2458 terrill.bravender@nationwidechildrens.org
Contact: Jules Arthur, MS (614) 722-2656 julianne.arthur@nationwidechildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Terrill Bravender, MD, MPH    614-722-2458    terrill.bravender@nationwidechildrens.org   
Principal Investigator: Terrill Bravender, MD, MPH         
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Terrill Bravender, MD, MPH 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: August 28, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 10, 2014