Study Stopped
Due to unforseen recruiting difficulties, the study was closed.
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2011
CompletedFirst Posted
Study publicly available on registry
June 14, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedNovember 15, 2016
February 1, 2016
1.2 years
June 10, 2011
November 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Self-reported anxiety
3 weeks
Study Arms (2)
Hydroxyzine
EXPERIMENTALHydroxyzine given TID
Sugar Pill
PLACEBO COMPARATORPlacebo given 3 times per day
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HealthPartners Institutelead
- Park Nicollet Eating Disorder Institutecollaborator
Study Sites (1)
Melrose Institute
Minneapolis, Minnesota, 55416, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcus Westerman, MD, PhD
Park Nicollet Melrose Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2011
First Posted
June 14, 2011
Study Start
January 1, 2012
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
November 15, 2016
Record last verified: 2016-02