Phase 4
N=41
A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
Anorexia Nervosa
Bottom Line
View on ClinicalTrials.gov: NCT00140426 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Change in Eating Disorder Inventory-2 Drive for Thinness Subscale (DT) — 1.36; 3.93 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Risperidone (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Eating Disorder Inventory-2 Drive for Thinness Subscale (DT) |
1.36; 3.93 | — |
| PRIMARY Change in Eating Disorder Inventory (EDI)-2 Score for Body Dissatisfaction (BD) |
0.82; 2.67 | — |
| PRIMARY Hazard Ratio for Time to Reaching Ease Of Eating Level 3 From Start of Study (Normal Eating Behavior) |
0.85; 1 | 0.55 |
| PRIMARY Color A Person Test (CAPT) |
0.03; 0.22 | 0.47 |
| PRIMARY Body Image Software (BIS): Average Distortion |
-0.22; 1.40 | 0.57 |
| PRIMARY Body Image Software (BIS): Average Desired Thinness |
1.88; -1.42 | 0.50 |
| PRIMARY Body Image Software (BIS) - Point of Subjective Equality (PSE) |
-0.32; -2.18 | 0.43 |
| PRIMARY Body Image Software (BIS) - Difference Limen (DL) |
-0.19; -1.16 | 0.12 |
| SECONDARY Time to Reach 90% Ideal Body Weight (IBW) and Maintain for 1 Month, Stratified by >=80% at Start of Study |
10.7; 8.1 | — |
| SECONDARY Change in Ratings of Anxiety Symptoms on the Multidimensional Anxiety Scale for Children (MASC) |
7.41; 7.87 | — |
| SECONDARY Change in Leptin Levels |
0.88; 3.27 | — |
| SECONDARY Change in Prolactin Levels |
-5.18; 38.27 | 0.10 |
| SECONDARY Time to Reach 90% IBW and Maintain for 1 Month, Stratified by IBW <80% at Start of Study |
10.1; 12.9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00140426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.