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

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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
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Risperidone
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 22 19
Completed 22 16
Not Completed 0 3
Reason Not Completed
Withdrawal by Subject             0             3
Arm/Group Title Placebo Risperidone Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 22 19 41
Hide Baseline Analysis Population Description
Females age 12 - 21
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 19 participants 41 participants
<=18 years
19
  86.4%
13
  68.4%
32
  78.0%
Between 18 and 65 years
3
  13.6%
6
  31.6%
9
  22.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 19 participants 41 participants
15.8  (2.3) 16.2  (2.5) 15.98  (2.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 19 participants 41 participants
Female
22
 100.0%
19
 100.0%
41
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 19 participants 41 participants
22 19 41
1.Primary Outcome
Title Change in Eating Disorder Inventory-2 Drive for Thinness Subscale (DT)
Hide Description

Eating Disorder Inventory -2 - Subscale : Drive for Thinness Subscale (DT). Lower scores are better on this scale and indicate less cognitive focus on drive for thinness.

The EDI 2 is a 91 item scale with 8 subscales - (Drive for thinness, Bulimia, body dissatisfaction, ineffectiveness, perfection, interpersonal distrust, interoceptive awareness and maturity fears.). The DT subscale was used for this outcome. Respondents rate each item as "usually , often, sometimes, rarely or never". Subscale scores are computed by summing all item scores for each subscale. There are 7 items in the DT subscale (questions 1,7,11,16,25,32 and 49). the subscale score range is 0-21. The EDI-2 was completed by subjects at baseline and then monthly during study participation (range 0 -18 weeks). Change in the DT subscale score was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.

Time Frame month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Risperidone
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.36  (5.09) 3.93  (6.95)
2.Primary Outcome
Title Change in Eating Disorder Inventory (EDI)-2 Score for Body Dissatisfaction (BD)
Hide Description

change in Eating Disorder Inventory (EDI) 2-score for Body Dissatisfaction (BD).

Lower scores are better on this scale. Higher scores indicate the subject has greater body dissatisfaction. BD is one of the 8 subscales of the EDI-2. 9 of the 91 questions in the EDI-2 scale constitute this subscale. The score range is 0-27. Subjects completed the EDI-2 at baseline and monthly during study participation (range 0 to 18 weeks). Change in the BD subscale score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.

Time Frame monthly
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
1 risperidone subject was missing data for BD at this data point.
Arm/Group Title Placebo Risperidone
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.82  (5.96) 2.67  (7.93)
3.Primary Outcome
Title Hazard Ratio for Time to Reaching Ease Of Eating Level 3 From Start of Study (Normal Eating Behavior)
Hide Description

The Ease of Eating Scale (EOES) is a 14 item scale which measures Food avoidance behaviors (FABs). The scale is rated by staff observing a subject eating a meal or snack. 0 = normal eating behavior, maximum score 28.

Higher scores indicate more food avoidance behaviors, such as taking small bites, taking > 30 seconds between bites (slow eating), etc.

EOE was completed for each meal a subject ate in the program and scores were averaged for each week in the study and entered in the data base.

Change in EOES score was calculated by evaluating change over time. This measure was only used in Phase 1 of the study, for days the subjects were in the treatment program.

Time Frame weekly up to study endpoint: reaching target weight and maintaining for 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 patients in the placebo group were treated as inpatients and had no EOE data.
Arm/Group Title Placebo Risperidone
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 20 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: hazard ratio
0.85
(0.41 to 1.74)
1
(1 to 1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risperidone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Regression, Cox
Comments Time to reaching ease of eating level 3 assessed using Cox regression as some patients did not reach it during the study.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.41 to 1.74
Estimation Comments The hazard ratio is for the placebo group versus the treatment group. A hazard ratio <1 implies that the placebo group had a lower risk of achieving EOE level 3, although not statistically significant. Achieving EOE level 3 was the desired endpoint.
4.Primary Outcome
Title Color A Person Test (CAPT)
Hide Description

Color A Person Test (CAPT) - Subjects color an outlined image of a body to indicate body dissatisfaction (red (5)= very dissatisfied, Yellow, dissatisfied, black, neutral, green satisfied, blue very satisfied (1). The outline is divided into16 sections for scoring. The CAPT was completed at baseline and monthly during study participation.

Total CAPT scores were calculated by adding the total score and dividing by 16. Score range is 1-5. Lower scores indicate less body dissatisfaction.

Change in the CAPT score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.

Time Frame monthly
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Risperidone or Placebo Risperidone
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.03  (0.75) 0.22  (0.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risperidone or Placebo, Risperidone
Comments Null hypothesis: no difference in change from baseline to end of treatment for CAPT total score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.71 to 0.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.26
Estimation Comments The mean difference was for placebo - risperidone.
5.Primary Outcome
Title Body Image Software (BIS): Average Distortion
Hide Description

Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer using the direction to "adjust their image to how they see themselves right now", this determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image.

Change in the BIS Average Distortion score during the study was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.

There are no identifiable minimum/maximum values as there would be in a questionnaire scale. There are no subscales. The BIS program calculates the difference between their actual image and the size of the image they have adjusted the digital image to based on their perception of "how they see themselves right now"

Time Frame monthly
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Change from baseline to end of study was compared between arms. Some patients did not complete this outcome measurement.
Arm/Group Title Risperidone or Placebo Risperidone
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 21 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.22  (8.75) 1.40  (8.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risperidone or Placebo, Risperidone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Primary Outcome
Title Body Image Software (BIS): Average Desired Thinness
Hide Description

Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to "their desired image". The BIS program calculates the difference between their actual image, and how much they have adjusted the image to represent their "desired image". Accuracy is measured by a smaller score between desired image and actual image.

Change in BIS - Average Desired Thinness score was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.

There are no identifiable minimum/maximum values as there would be in a questionnaire scale. . There are no subscales.

Time Frame monthly
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Many patients did not complete this outcome measurement. Change from baseline to end of study were compared between arms.
Arm/Group Title Risperidone or Placebo Risperidone
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 10 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.88  (9.24) -1.42  (10.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risperidone or Placebo, Risperidone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Primary Outcome
Title Body Image Software (BIS) - Point of Subjective Equality (PSE)
Hide Description

Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to their desired image, and also completes a task that determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image.

Change in BIS -PSE was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.

There are no identifiable minimum/maximum values as there would be in a questionnaire scale. Interpreting the PSE is how it compares to a PSE = 0, which is no distortion in body size.

Time Frame monthly
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Change from baseline to end of study was compared between arms. Some patients did not complete this outcome measurement.
Arm/Group Title Risperidone or Placebo Risperidone
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 19 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.32  (5.81) -2.18  (7.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risperidone or Placebo, Risperidone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Primary Outcome
Title Body Image Software (BIS) - Difference Limen (DL)
Hide Description

Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to their desired image, and also completes a task that determines their perception of their current image. Accuracy is measured by a smaller score between desired image and actual image.

Change in BIS-DL was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.

There are no identifiable minimum/maximum values as there would be in a questionnaire scale. There are no subscales. Interpreting the DL occurs by referencing it to DL= 0, which would reflect a total inability to detect size differences, which has never occurred in studies using the BIS program.

Time Frame monthly
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Change from baseline to end of study was compared between arms. Some patients did not complete this outcome measurement.
Arm/Group Title Risperidone or Placebo Risperidone
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 19 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.19  (1.10) -1.16  (2.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risperidone or Placebo, Risperidone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Time to Reach 90% Ideal Body Weight (IBW) and Maintain for 1 Month, Stratified by >=80% at Start of Study
Hide Description The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. These estimates were produced using Kaplan-Meier probabilities. This was measured weekly from 0-18 weeks.
Time Frame weekly
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Risperidone
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 10 6
Mean (Standard Error)
Unit of Measure: weeks
10.7  (1.6) 8.1  (0.2)
10.Secondary Outcome
Title Change in Ratings of Anxiety Symptoms on the Multidimensional Anxiety Scale for Children (MASC)
Hide Description

The Multidimensional Anxiety Scale for Children (MASC) is a self report measure completed by the subject that measures anxiety symptoms.

Higher scores indicate greater anxiety. A score of over 50 is significant for anxiety

Change in MASC scores was calculated using an estimate of change in score between week 0 and week 7 derived from the mixed effect model across all time points.

Time Frame monthly to study end point
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Risperidone
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 18 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.41  (7.87) 7.87  (11.19)
11.Secondary Outcome
Title Change in Leptin Levels
Hide Description Leptin levels were measured by serum blood draws, results reports in nanograms / ml (ng/ml).
Time Frame Week 0 and week 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Risperidone
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 19 12
Mean (Standard Deviation)
Unit of Measure: ng/ml
0.88  (4.13) 3.27  (3.04)
12.Secondary Outcome
Title Change in Prolactin Levels
Hide Description Prolactin serum blood levels, measured in nanograms / ml
Time Frame week 0 and week 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Risperidone
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 19 12
Mean (Standard Deviation)
Unit of Measure: ng/ml
-5.18  (5.89) 38.27  (33.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risperidone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.38
Parameter Dispersion
Type: Standard Deviation
Value: 3.74
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Risperidone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -43.45
Parameter Dispersion
Type: Standard Deviation
Value: 20.88
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Time to Reach 90% IBW and Maintain for 1 Month, Stratified by IBW <80% at Start of Study
Hide Description The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time. These estimates were produced using Kaplan-Meier probabilities.
Time Frame 0 - 18 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Risperidone
Hide Arm/Group Description:

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

This subject group received placebo tablets which appeared identical to risperidone

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

Risperidone: this group of patients received the active study medication. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW.

Overall Number of Participants Analyzed 12 12
Mean (Standard Error)
Unit of Measure: weeks
10.1  (0.4) 12.9  (1.3)
Time Frame While patients were on the study medication (placebo or risperidone)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Risperidone
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Placebo Risperidone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Risperidone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Risperidone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/22 (77.27%)      16/18 (88.89%)    
Gastrointestinal disorders     
gastrointestinal complaints   13/22 (59.09%)  53 7/18 (38.89%)  35
Musculoskeletal and connective tissue disorders     
Extrapyramidal symptoms (EPS)  [1]  8/22 (36.36%)  46 8/18 (44.44%)  19
Nervous system disorders     
Fatigue   8/22 (36.36%)  22 11/18 (61.11%)  39
dizziness   4/22 (18.18%)  4 4/18 (22.22%)  15
headache   8/22 (36.36%)  8 4/18 (22.22%)  5
insomnia   2/22 (9.09%)  4 0/18 (0.00%)  0
Tardive dyskinesia  [2]  1/22 (4.55%)  2 6/18 (33.33%)  14
Psychiatric disorders     
Depression   0/22 (0.00%)  0 2/18 (11.11%)  2
Anxiety   3/22 (13.64%)  6 1/18 (5.56%)  1
Indicates events were collected by systematic assessment
[1]
Measured on the Simpson rating scale
[2]
as measured by the Abnormal Involuntary Movement Scale (AIMS)
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
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