Does Hydroxyzine Decrease Anxiety in Underweight Patients Diagnosed With an Eating Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Hydroxyzine Effects on Meal-Related Anxiety in Underweight Adolescents and Young Adults Diagnosed With an Eating Disorder - A Pilot Study

Conditions
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Anxiety in Those Patients With Anorexia Nervosa, Eating Disorder Not Otherwise Specified, BMI (<=18)

Intervention / Treatment
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* Drug: Hydroxyzine
* Drug: hydroxyzine HCL
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to the Intensive Structured Living Unit (ISL) at Melrose Institute for treatment of an eating disorder that meets DSM-IV criteria for Anorexia Nervosa (excluding the amenorrhea criterion), or Eating Disorder Not Otherwise Specified, specifically with BMI (≤ 18) Age 8-25 years old at admission to ISL. Weight ≥ 15 kg at admission to ISL. Stable psychotropic and/or sedative medications for at least (≥) 6 weeks Exclusion Criteria: Age < 8 years Age ≥ 25 years Weight < 15 kg at admission to ISL Prolonged QT interval on ECG at admission to ISL Current substance or alcohol abuse or dependence Malabsorption syndrome or inability to take oral medications History of hydroxyzine intolerance or hypersensitivity History of Type 1 Diabetes Mellitus History of angle closure glaucoma Currently on another clinical trial Pregnancy

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxyzine<br>Hydroxyzine given TID | Drug: Hydroxyzine<br>* 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<br>Drug: hydroxyzine HCL<br>* hydroxyzine HCL dosed on weight given 3x per day<br>|
| Placebo Comparator: Sugar Pill<br>Placebo given 3 times per day | Other: Placebo<br>* Placebo given 3 times per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported anxiety |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treating meal related anxiety