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

HealthPartners Institute

Status and phase: Withdrawn; Phase 4

Conditions: Eating Disorder Not Otherwise Specified, BMI (<=18); Anxiety in Those Patients With Anorexia Nervosa

Treatments: Other: Placebo; Drug: Hydroxyzine; Drug: hydroxyzine HCL

Study type: Interventional

Funder types: Other

Identifiers

NCT01372670

04091-11

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 8 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

---

0 participants in 2 patient groups, including a placebo group

Hydroxyzine

Experimental group

Description:

Hydroxyzine given TID

Treatment:

Drug: Hydroxyzine

Drug: hydroxyzine HCL

Sugar Pill

Placebo Comparator group

Description:

Placebo given 3 times per day

Treatment:

Other: Placebo