Clinical trial NCT00140426: A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
Official title: A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anorexia Nervosa
Keywords: Anorexia Nervosa
Risperidone
Atypical Neuroleptics
Dopamine
Leptin
Body Image
Adolescents
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Janssen Pharmaceuticals
name: National Center for Research Resources (NCRR)
First posted: 2005-09-01
Enrollment: 41
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Eating Disorder Inventory-2 Drive for Thinness Subscale (DT)
timeFrame: month
measure: Change in Eating Disorder Inventory (EDI)-2 Score for Body Dissatisfaction (BD)
timeFrame: monthly
measure: Hazard Ratio for Time to Reaching Ease Of Eating Level 3 From Start of Study (Normal Eating Behavior)
timeFrame: weekly up to study endpoint: reaching target weight and maintaining for 1 month
measure: Color A Person Test (CAPT)
timeFrame: monthly
measure: Body Image Software (BIS): Average Distortion
timeFrame: monthly
measure: Body Image Software (BIS): Average Desired Thinness
timeFrame: monthly
measure: Body Image Software (BIS) - Point of Subjective Equality (PSE)
timeFrame: monthly
measure: Body Image Software (BIS) - Difference Limen (DL)
timeFrame: monthly
Secondary outcomes:
measure: Time to Reach 90% Ideal Body Weight (IBW) and Maintain for 1 Month, Stratified by >=80% at Start of Study
timeFrame: weekly
measure: Change in Ratings of Anxiety Symptoms on the Multidimensional Anxiety Scale for Children (MASC)
timeFrame: monthly to study end point
measure: Change in Leptin Levels
timeFrame: Week 0 and week 7
measure: Change in Prolactin Levels
timeFrame: week 0 and week 7
measure: Time to Reach 90% IBW and Maintain for 1 Month, Stratified by IBW <80% at Start of Study
timeFrame: 0 - 18 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: The Children's Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Health Sciences Center and The Children's Hospital, Denver
name: Jennifer O Hagman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.