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

• Status: Withdrawn
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HealthPartners Institute
• Collaborator: Park Nicollet Eating Disorder Institute
• Treatments: Hydroxyzine

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