Does Hydroxyzine Decrease Anxiety in Underweight Patients... | NCT01372670

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

NCT01372670

Sponsor

HealthPartners Institute

Status

Withdrawn

Last Update Posted

Nov 15, 2016Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

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

Interventions

Hydroxyzine
hydroxyzine HCL
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to unforseen recruiting difficulties, the study was closed.

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Jun 10, 2011

First Submission Date that Met QC Criteria

Jun 13, 2011

First Posted Date

Jun 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2016

Last Update Posted Date

Nov 15, 2016Estimated

Name	Class
Park Nicollet Eating Disorder Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hydroxyzine	Experimental	Hydroxyzine given TID	Drug: Hydroxyzine Drug: hydroxyzine HCL
Sugar Pill	Placebo Comparator	Placebo given 3 times per day	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydroxyzine	Drug	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

Measure	Description	Time Frame
Self-reported anxiety		3 weeks

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marcus Westerman, MD, PhD	Park Nicollet Melrose Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Melrose Institute		Minneapolis	Minnesota	55416	United States

Intervention Browse Module

MeSH Terms

ID	Term
D006919	Hydroxyzine

Ancestor Terms

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

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