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

November 14, 2016 updated by: HealthPartners Institute

Hydroxyzine Effects on Meal-Related Anxiety in Underweight Adolescents and Young Adults Diagnosed With an Eating Disorder - A Pilot Study

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Melrose Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydroxyzine
Hydroxyzine given TID
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
Placebo Comparator: Sugar Pill
Placebo given 3 times per day
Other: Placebo
Placebo given 3 times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-reported anxiety
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Collaborators

Park Nicollet Eating Disorder Institute

Investigators

  • Principal Investigator: Marcus Westerman, MD, PhD, Park Nicollet Melrose Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

June 10, 2011

First Submitted That Met QC Criteria

June 13, 2011

First Posted (Estimate)

June 14, 2011

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 14, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04091-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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