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

NCT ID: NCT00140426

Last Updated: 2016-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2009-12-31

Brief 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.

Detailed Description

The lack of effective medications for the symptoms of anorexia nervosa (AN), combined with 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.

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo

double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

risperidone

Study is double blind, placebo controlled. This is the subject group on active medication

Group Type: ACTIVE_COMPARATOR

Risperidone

Intervention Type: DRUG

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

Interventions

Risperidone

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Risperdal; placebo - inactive pill

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer O Hagman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Health Sciences Center and The Children's Hospital, Denver

Locations

The Children's Hospital

Denver, Colorado, United States

Countries

United States

References

Hagman J, Gralla J, Sigel E, Ellert S, Dodge M, Gardner R, O'Lonergan T, Frank G, Wamboldt MZ. A double-blind, placebo-controlled study of risperidone for the treatment of adolescents and young adults with anorexia nervosa: a pilot study. J Am Acad Child Adolesc Psychiatry. 2011 Sep;50(9):915-24. doi: 10.1016/j.jaac.2011.06.009. Epub 2011 Aug 5.

Reference Type: DERIVED

PMID: 21871373 (View on PubMed)

Other Identifiers

5M01RR000069-45

Identifier Type: NIH

Identifier Source: secondary_id

View Link

03-0673

Identifier Type: -

Identifier Source: org_study_id