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

NCT01372670 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2016-11-15

No results posted yet for this study

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.

Conditions

  • Anxiety in Those Patients With Anorexia Nervosa
  • Eating Disorder Not Otherwise Specified, 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

Sponsors & Collaborators

  • Park Nicollet Eating Disorder Institute

    collaborator OTHER

  • HealthPartners Institute

    lead OTHER

Principal Investigators

  • Marcus Westerman, MD, PhD · Park Nicollet Melrose Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01372670 on ClinicalTrials.gov