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

Overview

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.

Full Title of Study: “Hydroxyzine Effects on Meal-Related Anxiety in Underweight Adolescents and Young Adults Diagnosed With an Eating Disorder – A Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: April 2013

Detailed Description

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).

Interventions

  • Drug: Hydroxyzine
    • 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
  • Drug: hydroxyzine HCL
    • hydroxyzine HCL dosed on weight given 3x per day
  • Other: Placebo
    • Placebo given 3 times per day

Arms, Groups and Cohorts

  • Experimental: Hydroxyzine
    • Hydroxyzine given TID
  • Placebo Comparator: Sugar Pill
    • Placebo given 3 times per day

Clinical Trial Outcome Measures

Primary Measures

  • Self-reported anxiety
    • Time Frame: 3 weeks

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 8 Years

    Maximum Age: 25 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • HealthPartners Institute
    • Collaborator
      • Park Nicollet Eating Disorder Institute
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Marcus Westerman, MD, PhD, Principal Investigator, Park Nicollet Melrose Institute

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