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



Status:Withdrawn
Conditions:Anxiety, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:8 - 25
Updated:4/21/2016
Start Date:January 2012
End Date:April 2013

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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.

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).

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
We found this trial at
1
site
Minneapolis, Minnesota 55416
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Minneapolis, MN
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