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Does Hydroxyzine Decrease Anxiety in Patients With Anorexia Nervosa Study

Information source: Park Nicollet Institute
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anxiety in Anorexia Nervosa

Intervention: Hydroxyzine (Drug); hydroxyzine HCL (Drug); Placebo (Other)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Park Nicollet Institute

Summary

The purpose of this study is to determine the effectiveness of hydroxyzine in the treatment of meal-related anxiety in children and adolescents 8 to 17 years of age diagnosed with anorexia nervosa. The investigators want to find out if hydroxyzine given before meals will improve meal-related anxiety compared to no hydroxyzine.

Clinical Details

Official title: Hydroxyzine Effects on Meal-Related Anxiety in Anorexia Nervosa-

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Self-reported anxiety

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). To our knowledge, hydroxyzine has never been formally investigated in treating meal-related anxiety and improving outcomes in patients with anorexia nervosa (AN).

Eligibility

Minimum age: 8 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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.

- Age 8-17 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 ≥ 18 years

- Weight < 15 kg 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

Locations and Contacts

Park Nicollet Melrose Institute, St Louis Park, Minnesota 55416, United States
Additional Information

Melrose Institute for Eating Disorders Research

Starting date: September 2011
Last updated: July 7, 2011

Page last updated: December 08, 2011

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