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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00140426
Recruitment Status : Completed
First Posted : September 1, 2005
Results First Posted : February 2, 2016
Last Update Posted : February 2, 2016
Sponsor:
Collaborators:
Janssen Pharmaceuticals
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Anorexia Nervosa
Interventions: Drug: Risperidone
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo

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

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

Risperidone

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

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.


Participant Flow:   Overall Study
    Placebo   Risperidone
STARTED   22   19 
COMPLETED   22   16 
NOT COMPLETED   0   3 
Withdrawal by Subject                0                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Females age 12 - 21

Reporting Groups
  Description
Placebo

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

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

Risperidone

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

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.

Total Total of all reporting groups

Baseline Measures
   Placebo   Risperidone   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   19   41 
Age 
[Units: Participants]
     
<=18 years   19   13   32 
Between 18 and 65 years   3   6   9 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.8  (2.3)   16.2  (2.5)   15.98  (2.35) 
Gender 
[Units: Participants]
     
Female   22   19   41 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   22   19   41 


  Outcome Measures

1.  Primary:   Change in Eating Disorder Inventory-2 Drive for Thinness Subscale (DT)   [ Time Frame: month ]

2.  Primary:   Change in Eating Disorder Inventory (EDI)-2 Score for Body Dissatisfaction (BD)   [ Time Frame: monthly ]

3.  Primary:   Hazard Ratio for Time to Reaching Ease Of Eating Level 3 From Start of Study (Normal Eating Behavior)   [ Time Frame: weekly up to study endpoint: reaching target weight and maintaining for 1 month ]

4.  Primary:   Color A Person Test (CAPT)   [ Time Frame: monthly ]

5.  Primary:   Body Image Software (BIS): Average Distortion   [ Time Frame: monthly ]

6.  Primary:   Body Image Software (BIS): Average Desired Thinness   [ Time Frame: monthly ]

7.  Primary:   Body Image Software (BIS) - Point of Subjective Equality (PSE)   [ Time Frame: monthly ]

8.  Primary:   Body Image Software (BIS) - Difference Limen (DL)   [ Time Frame: monthly ]

9.  Secondary:   Time to Reach 90% Ideal Body Weight (IBW) and Maintain for 1 Month, Stratified by >=80% at Start of Study   [ Time Frame: weekly ]

10.  Secondary:   Change in Ratings of Anxiety Symptoms on the Multidimensional Anxiety Scale for Children (MASC)   [ Time Frame: monthly to study end point ]

11.  Secondary:   Change in Leptin Levels   [ Time Frame: Week 0 and week 7 ]

12.  Secondary:   Change in Prolactin Levels   [ Time Frame: week 0 and week 7 ]

13.  Secondary:   Time to Reach 90% IBW and Maintain for 1 Month, Stratified by IBW <80% at Start of Study   [ Time Frame: 0 - 18 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jennifer Hagman MD
Organization: University of Colorado School of Medicine, Childrens Hospital Colorado
phone: 720-777-2539
e-mail: jennifer.hagman@childrenscolorado.org


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: 03-0673
5M01RR000069-45 ( U.S. NIH Grant/Contract )
First Submitted: August 31, 2005
First Posted: September 1, 2005
Results First Submitted: June 8, 2015
Results First Posted: February 2, 2016
Last Update Posted: February 2, 2016