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

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01372670

Enrollment

Registered

2011-06-14

Start date

2012-01-31

Completion date

2013-04-30

Last updated

2016-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety in Those Patients With Anorexia Nervosa, Eating Disorder Not Otherwise Specified, BMI (<=18)

Keywords

Treating meal related anxiety

Brief 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.

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).

Interventions

DRUGHydroxyzine

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

DRUGhydroxyzine HCL

hydroxyzine HCL dosed on weight given 3x per day

OTHERPlacebo

Placebo given 3 times per day

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

8 Years to 25 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Self-reported anxiety	3 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026