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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01372670
Recruitment Status : Withdrawn (Due to unforseen recruiting difficulties, the study was closed.)
First Posted : June 14, 2011
Last Update Posted : November 15, 2016
Park Nicollet Eating Disorder Institute
Information provided by (Responsible Party):
HealthPartners Institute

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.

Condition or disease Intervention/treatment Phase
Anxiety in Those Patients With Anorexia Nervosa Eating Disorder Not Otherwise Specified, BMI (<=18) Drug: Hydroxyzine Drug: hydroxyzine HCL Other: Placebo Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Hydroxyzine Effects on Meal-Related Anxiety in Underweight Adolescents and Young Adults Diagnosed With an Eating Disorder - A Pilot Study
Study Start Date : January 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Hydroxyzine
Hydroxyzine given TID
Drug: 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

Drug: hydroxyzine HCL
hydroxyzine HCL dosed on weight given 3x per day

Placebo Comparator: Sugar Pill
Placebo given 3 times per day
Other: Placebo
Placebo given 3 times per day

Primary Outcome Measures :
  1. Self-reported anxiety [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01372670

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United States, Minnesota
Melrose Institute
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
HealthPartners Institute
Park Nicollet Eating Disorder Institute
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Principal Investigator: Marcus Westerman, MD, PhD Park Nicollet Melrose Institute
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Responsible Party: HealthPartners Institute Identifier: NCT01372670    
Other Study ID Numbers: 04091-11
First Posted: June 14, 2011    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: February 2016
Keywords provided by HealthPartners Institute:
Treating meal related anxiety
Additional relevant MeSH terms:
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Anxiety Disorders
Feeding and Eating Disorders
Anorexia Nervosa
Mental Disorders
Signs and Symptoms, Digestive
Body Weight
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs