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NCT01372670 Clinical Trial

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

Anxiety in Those Patients With Anorexia Nervosa Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01372670
Other study ID # 04091-11
Secondary ID
Status Withdrawn
Phase Phase 4
First received June 10, 2011
Last updated November 14, 2016
Start date January 2012
Est. completion date April 2013

Study information
Verified date February 2016
Source HealthPartners Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 25 Years
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

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
• hydroxyzine HCL
hydroxyzine HCL dosed on weight given 3x per day
Other:
• Placebo
Placebo given 3 times per day

Locations
Country Name City State
United States Melrose Institute Minneapolis Minnesota

Sponsors (2)
Lead Sponsor Collaborator
HealthPartners Institute Park Nicollet Eating Disorder Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Self-reported anxiety 3 weeks No

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