A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
This study is ongoing, but not recruiting participants.
Sponsor:
University of Colorado, Denver
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
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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
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 Anorexia Nervosa Signs and Symptoms, Digestive Signs and Symptoms Eating Disorders Mental Disorders 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 May 22, 2013