WithdrawnPhase 4

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

Stopped: Due to unforseen recruiting difficulties, the study was closed.

United States0Started 2012-01

Plain-language 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.

Who can participate

Age range

8 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Self-reported anxiety

Timeframe: 3 weeks

Trial details

NCT IDNCT01372670

SponsorHealthPartners Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-04

View on ClinicalTrials.gov More Anxiety in Those Patients With Anorexia Nervosa trials