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A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa

NCT00140426 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2016-02-02

Study results available
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Summary

The aim of this pilot study is to determine the safety and efficacy of risperidone for the treatment of anorexia nervosa.

Hypothesis 1: Subjects on risperidone will show a more significant decrease in body image distortion and Eating Disorder Inventory -2 scores than subjects on placebo.

Hypothesis 2: Subjects on risperidone will reach and maintain at or above 90% Ideal body weight sooner than controls.

Conditions

  • Anorexia Nervosa

Interventions

DRUG

Risperidone

risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks.

DRUG

Placebo

Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa.

Sponsors & Collaborators

  • Janssen Pharmaceuticals

    collaborator INDUSTRY

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Jennifer O Hagman, MD · University of Colorado, Health Sciences Center and The Children's Hospital, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00140426 on ClinicalTrials.gov