A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
Sponsors
Lead Sponsor
Collaborators
Source
University of Colorado, Denver
Oversight Info
Has Dmc
Yes
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.
Overall Status
Completed
Start Date
2004-08-01
Completion Date
2009-12-01
Primary Completion Date
2009-12-01
Phase
Phase 4
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Change in Eating Disorder Inventory-2 Drive for Thinness Subscale (DT) |
month |
|
Change in Eating Disorder Inventory (EDI)-2 Score for Body Dissatisfaction (BD) |
monthly |
|
Hazard Ratio for Time to Reaching Ease Of Eating Level 3 From Start of Study (Normal Eating Behavior) |
weekly up to study endpoint: reaching target weight and maintaining for 1 month |
|
Color A Person Test (CAPT) |
monthly |
|
Body Image Software (BIS): Average Distortion |
monthly |
|
Body Image Software (BIS): Average Desired Thinness |
monthly |
|
Body Image Software (BIS) - Point of Subjective Equality (PSE) |
monthly |
|
Body Image Software (BIS) - Difference Limen (DL) |
monthly |
Secondary Outcome
Measure |
Time Frame |
|
Time to Reach 90% Ideal Body Weight (IBW) and Maintain for 1 Month, Stratified by >=80% at Start of Study |
weekly |
|
Change in Ratings of Anxiety Symptoms on the Multidimensional Anxiety Scale for Children (MASC) |
monthly to study end point |
|
Change in Leptin Levels |
Week 0 and week 7 |
|
Change in Prolactin Levels |
week 0 and week 7 |
|
Time to Reach 90% IBW and Maintain for 1 Month, Stratified by IBW <80% at Start of Study |
0 - 18 weeks |
Enrollment
41
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks.
Arm Group Label
risperidone
Other Name
Risperdal
Intervention Type
Drug
Intervention Name
Description
Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa.
Arm Group Label
placebo
Other Name
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
Gender
Female
Minimum Age
12 Years
Maximum Age
21 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Jennifer O Hagman, MD |
Principal Investigator |
University of Colorado, Health Sciences Center and The Children's Hospital, Denver |
Location
Facility |
|
The Children's Hospital Denver Colorado 80218 United States |
Location Countries
Country
United States
Verification Date
2015-12-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
5M01RR000069-45
Number Of Arms
2
Intervention Browse
Mesh Term
Risperidone
Arm Group
Arm Group Label
placebo
Arm Group Type
Placebo Comparator
Description
double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.
Arm Group Label
risperidone
Arm Group Type
Active Comparator
Description
Study is double blind, placebo controlled. This is the subject group on active medication
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
August 31, 2005
Study First Submitted Qc
August 31, 2005
Study First Posted
September 1, 2005
Last Update Submitted
December 29, 2015
Last Update Submitted Qc
December 29, 2015
Last Update Posted
February 2, 2016
Results First Submitted
June 8, 2015
Results First Submitted Qc
December 29, 2015
Results First Posted
February 2, 2016
ClinicalTrials.gov processed this data on August 31, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.