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Withdrawn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
Sponsored by
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
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Withdrawn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
No
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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