Text Size

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

This study has been terminated.
(Due to unforseen recruiting difficulties, the study was closed.)
Sponsor:
Collaborator:
Park Nicollet Eating Disorder Institute
Information provided by (Responsible Party):
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT01372670
First received: June 10, 2011
Last updated: May 15, 2013
Last verified: June 2011
History of Changes
  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 or Eating Disorder Not Otherwise Specified, Specifically With Low BMI(≤ 18).
 Drug: Hydroxyzine
Drug: hydroxyzine HCL
Other: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Park Nicollet Institute:

Primary Outcome Measures:
  • Self-reported anxiety [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: January 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: March 2014 (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

Ages Eligible for Study:   8 Years to 25 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372670

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

Additional Information:
Melrose Institute for Eating Disorders Research  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Park Nicollet Institute
ClinicalTrials.gov Identifier: NCT01372670     History of Changes
Other Study ID Numbers: 04091-11
Study First Received: June 10, 2011
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Park Nicollet Institute:
Treating meal related anxiety

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

ClinicalTrials.gov processed this record on June 18, 2013