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

Primary Purpose

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

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Hydroxyzine

hydroxyzine HCL

Placebo

About this trial

This is an interventional treatment trial for Anxiety in Those Patients With Anorexia Nervosa focused on measuring Treating meal related anxiety

Eligibility Criteria

8 Years - 25 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Melrose Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydroxyzine

Sugar Pill

Arm Description

Hydroxyzine given TID

Placebo given 3 times per day

Outcomes

Primary Outcome Measures

Self-reported anxiety

Secondary Outcome Measures

Full Information

NCT ID

NCT01372670

First Posted

June 10, 2011

Last Updated

November 14, 2016

Sponsor

HealthPartners Institute

Collaborators

Park Nicollet Eating Disorder Institute

1. Study Identification

Unique Protocol Identification Number

NCT01372670

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Due to unforseen recruiting difficulties, the study was closed.

Study Start Date

January 2012 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HealthPartners Institute

Collaborators

Park Nicollet Eating Disorder Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Treating meal related anxiety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hydroxyzine

Arm Type

Experimental

Arm Description

Hydroxyzine given TID

Arm Title

Sugar Pill

Arm Type

Placebo Comparator

Arm Description

Placebo given 3 times per day

Intervention Type

Drug

Intervention Name(s)

Hydroxyzine

Intervention Description

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

Intervention Name(s)

hydroxyzine HCL

Intervention Description

hydroxyzine HCL dosed on weight given 3x per day

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo given 3 times per day

Primary Outcome Measure Information:

Title

Self-reported anxiety

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcus Westerman, MD, PhD

Organizational Affiliation

Park Nicollet Melrose Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Melrose Institute

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

12. IPD Sharing Statement

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

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