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

NCT ID: NCT01372670

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-04-30

Brief Summary

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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

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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).

Conditions

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

Keywords

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Treating meal related anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Hydroxyzine

Hydroxyzine given TID

Group Type EXPERIMENTAL

Hydroxyzine

Intervention Type DRUG

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

Intervention Type DRUG

hydroxyzine HCL dosed on weight given 3x per day

Sugar Pill

Placebo given 3 times per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo given 3 times per day

Interventions

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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

Intervention Type DRUG

hydroxyzine HCL

hydroxyzine HCL dosed on weight given 3x per day

Intervention Type DRUG

Placebo

Placebo given 3 times per day

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Park Nicollet Eating Disorder Institute

OTHER

Sponsor Role collaborator

HealthPartners Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcus Westerman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Park Nicollet Melrose Institute

Locations

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Melrose Institute

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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04091-11

Identifier Type: -

Identifier Source: org_study_id