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
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