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

Phase 4

Withdrawn

• Conditions: Anxiety in Those Patients With Anorexia Nervosa; Eating Disorder Not Otherwise Specified, BMI (<=18)
• Interventions: Other: Placebo; Drug: Hydroxyzine; Drug: hydroxyzine HCL

• Registration Number: NCT01372670
• Lead Sponsor: HealthPartners Institute

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2011-06-10
• Study First Submitted QC: 2011-06-13
• Study First Posted: 2011-06-14
• Study Start: 2012-01
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2016-02
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sugar Pill	Placebo	Placebo given 3 times per day
Hydroxyzine	Hydroxyzine	Hydroxyzine given TID
Hydroxyzine	hydroxyzine HCL	Hydroxyzine given TID

Primary Outcome Measures

Name	Time	Method
Self-reported anxiety	3 weeks

Trial Locations

Locations (1)

Melrose Institute; 🇺🇸 Minneapolis, Minnesota, United States