A Phase 4 interventional study of Hydroxyzine and hydroxyzine HCL in Anxiety in Those Patients With Anorexia Nervosa and Eating Disorder Not Otherwise Specified, BMI (<=18), sponsored by HealthPartners Institute. Withdrawn at 1 site in United States. Open to participants aged 8 Years to 25 Years. Per ClinicalTrials.gov, last updated 2016-11-15.
Sponsored by HealthPartners Institute · Phase 4, Interventional, and Treatment
The purpose of this study is to determine the effectiveness of hydroxyzine in the treatment of meal-related anxiety in adolescents and young adults 8 to 25 years of age diagnosed with an eating disorder who are underweight. The investigators want to find out if hydroxyzine given before meals will improve meal-related anxiety compared to no hydroxyzine.
This study is a practiced-based pilot study in follow-up to clinical observations made by our treatment team that hydroxyzine attenuates meal-related anxiety and improves treatment adherence in patients with a diagnosis of Anorexia Nervosa (AN) (excluding the amenorrhea criterion) or Eating Disorder Not Otherwise Specified (EDNOS) specifically with low BMI (≤ 18). To our knowledge, hydroxyzine has never been formally investigated in treating meal-related anxiety and improving outcomes in patients with AN or EDNOS specifically with low BMI (≤ 18).
HealthPartners Institute is the lead sponsor of 166 studies on the registry; 20 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.
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Exclusion Criteria:
Hydroxyzine given TID
Drug: Hydroxyzine · Drug: hydroxyzine HCL
Placebo given 3 times per day
Other: Placebo
Study medications (hydroxyzine/placebo) will be dosed based on participant's weight. Dosing will be according to the following body weight ranges: 15-29 Kg 10 mg TID 30-44 Kg 20 mg TID ≥ 45 Kg 30 mg TID
hydroxyzine HCL dosed on weight given 3x per day
Placebo given 3 times per day
Self-reported anxiety
Time frame: 3 weeks
The record gives a start of Jan 2012, a primary completion of Apr 2013 and a completion of Apr 2013. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydroxyzine