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

This study has been withdrawn prior to enrollment.
(Due to unforseen recruiting difficulties, the study was closed.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01372670
First Posted: June 14, 2011
Last Update Posted: November 15, 2016
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.
Collaborator:
Park Nicollet Eating Disorder Institute
Information provided by (Responsible Party):
HealthPartners Institute
  Purpose
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 Intervention Phase
Anxiety in Those Patients With Anorexia Nervosa Eating Disorder Not Otherwise Specified, BMI (<=18) Drug: Hydroxyzine Drug: hydroxyzine HCL Other: Placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by HealthPartners Institute:

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

Enrollment: 0
Study Start Date: January 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).
  Eligibility

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01372670


Locations
United States, Minnesota
Melrose Institute
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
HealthPartners Institute
Park Nicollet Eating Disorder Institute
Investigators
Principal Investigator: Marcus Westerman, MD, PhD Park Nicollet Melrose Institute
  More Information

Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT01372670     History of Changes
Other Study ID Numbers: 04091-11
First Submitted: June 10, 2011
First Posted: June 14, 2011
Last Update Posted: November 15, 2016
Last Verified: February 2016

Keywords provided by HealthPartners Institute:
Treating meal related anxiety

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Feeding and Eating Disorders
Anorexia
Anorexia Nervosa
Thinness
Pathologic Processes
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Body Weight
Hydroxyzine
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs