Trials / Withdrawn
WithdrawnNCT01372670
Does Hydroxyzine Decrease Anxiety in Underweight Patients Diagnosed With an Eating Disorder
Hydroxyzine Effects on Meal-Related Anxiety in Underweight Adolescents and Young Adults Diagnosed With an Eating Disorder - A Pilot Study
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- HealthPartners Institute · Academic / Other
- Sex
- All
- Age
- 8 Years – 25 Years
- Healthy volunteers
- Not accepted
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.
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| OTHER | Placebo | Placebo given 3 times per day |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2013-04-01
- Completion
- 2013-04-01
- First posted
- 2011-06-14
- Last updated
- 2016-11-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01372670. Inclusion in this directory is not an endorsement.