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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00140426
First received: August 31, 2005
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Anorexia Nervosa
Drug: Risperidone or placebo
Drug: Risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Change in body image distortion and body satisfaction [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • Change in Eating Disorder Inventory-2 Score [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • Number of days from start of study to reach ease of eating level 3 (Normal eating behavior) [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to reach 90% ideal body weight (IBW) and maintain for 1 month, stratified by %IBW at start of study [ Time Frame: weekly ] [ Designated as safety issue: No ]
  • Change in ratings of anxiety symptoms on the MASC [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • Change in leptin levels [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
  • Safety and tolerability of risperidone as measured by liver enzymes, prolactin levels, triglycerides, glucose, cholesterol, ECG, resting energy expenditure (REE) and side effect rating scales - Simpson and AIMS. [ Time Frame: baseline, week 8 and study end visit ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: August 2004
Estimated Study Completion Date: July 2013
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: risperidone or placebo
double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
Drug: Risperidone or placebo
risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks.
Other Name: Risperdal
Active Comparator: risperidone
Study is double blind, placebo controlled. This is the subject group on active medication
Drug: Risperidone
Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW.
Other Name: risperdal

Detailed Description:

The lack of effective medications for the symptoms of anorexia nervosa (AN), combined wit early promising findings in case reports (Risperidone and Olanzapine) and one open study of olanzapine have led to increased use of these medications for individuals with AN. This double-blind placebo controlled study of risperidone will attempt to determine if risperidone is effective in decreasing core symptoms of anorexia nervosa and decreasing the length of time required to reach and maintain at or about 90% Ideal body weight. The safety of risperidone in this population will also be examined through monitoring of Extrapyramidal Symptoms, Tardive Dyskinesia, Electrocardiograms's, Resting Energy Expenditure, liver enzymes and other blood chemistry. Other possible variables which may mediate the recovery process or be impacted by risperidone,such as leptin and anxiety symptoms are also being measured.

  Eligibility

Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary Diagnosis of Anorexia Nervosa
  • Female, age 12-21
  • Active in a level of care for AN at The Children's Hospital, Denver
  • As long as there is a primary dx of AN, co-morbid diagnoses may be included.
  • If taking an antidepressant, must be on a stable dose for 3 weeks prior to entering the study, and dose of antidepressant may not be changed during Phase 1 of the study.
  • If choosing to discontinue antidepressant medication, must be off the medication for 3 weeks prior to beginning the study.
  • If sexually active, must use birth control during the study and have a monthly pregnancy test.

Exclusion Criteria:

  • Previous enrollment in this study on a prior admission
  • Previous allergic reaction to risperidone or other atypical neuroleptic
  • Positive pregnancy test
  • Neurologic disorder other than benign essential tremor
  • Taking a psychotropic medication other than antidepressant and discontinuing the medication is not recommended.
  • Active hepatic or renal disease
  • Wards of the state
  • Males
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140426

Locations
United States, Colorado
The Children's Hospital
Denver, Colorado, United States, 80218
Sponsors and Collaborators
University of Colorado, Denver
Janssen Pharmaceuticals
Investigators
Principal Investigator: Jennifer O Hagman, MD University of Colorado, Health Sciences Center and The Children's Hospital, Denver
  More Information

No publications provided by University of Colorado, Denver

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00140426     History of Changes
Other Study ID Numbers: 03-673, M01-RR00069
Study First Received: August 31, 2005
Last Updated: March 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Anorexia Nervosa
Risperidone
Atypical Neuroleptics
Dopamine
Leptin
Body Image
Adolescents

Additional relevant MeSH terms:
Anorexia Nervosa
Anorexia
Eating Disorders
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 30, 2014