Phase 2
N=24
Treatment of Anxiety and Anorexia Nervosa in Adolescents
Anxiety · Anorexia Nervosa
Bottom Line
View on ClinicalTrials.gov: NCT01933243 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Medication Side Effects Score — 9.5; 6.2; 6.4; 4.1 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fish oil (Drug); Placebo pill (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Andrea Bonny
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medication Side Effects Score |
9.5; 6.2; 6.4; 4.1 | — |
| SECONDARY Beck Anxiety Inventory-Trait (BAIT) |
26.4; 19.3; 21.9; 11; 14.9; 6.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
Females admitted to Nationwide Children's Hospital Eating Disorder Partial Hospitalization Program
Exclusion Criteria
- Inability to take pills
- Co-morbid medical conditions affecting appetite and weight (e.g., inflammatory bowel disease, cancer, cystic fibrosis)
- Co-morbid psychiatric conditions affecting appetite and weight (e.g., bipolar disorder, substance abuse)
- Currently taking fish oil supplements
- Inability to participate in study for 12 consecutive weeks.
Data sourced from ClinicalTrials.gov (NCT01933243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.