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A Study of the Effectiveness and Safety of Two Doses of Risperidone in the Treatment of Children and Adolescents With Autistic Disorder

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: NCT00576732
Recruitment Status : Completed
First Posted : December 19, 2007
Results First Posted : September 28, 2010
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Autistic Disorder
Autism
Interventions Drug: Placebo
Drug: Risperidone high dose
Drug: Risperidone low dose
Enrollment 96
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Risperidone Low Dose Risperidone High Dose Placebo/RIS Ris Low Dose/RIS Ris High Dose/RIS
Hide Arm/Group Description Double-blind Period. Oral solution for 6 weeks. Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks. Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks. Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg). Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg). Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
Period Title: DOUBLE BLIND
Started 35 30 31 0 0 0
Completed 27 25 25 0 0 0
Not Completed 8 5 6 0 0 0
Reason Not Completed
Adverse Event             0             0             1             0             0             0
Lost to Follow-up             0             1             1             0             0             0
Withdrawal by Subject             1             1             3             0             0             0
OTHER             0             2             1             0             0             0
Lack of Efficacy             6             1             0             0             0             0
Protocol Violation             1             0             0             0             0             0
Period Title: OPEN LABEL
Started 0 0 0 30 [1] 24 [2] 25 [3]
Completed 0 0 0 19 20 17
Not Completed 0 0 0 11 4 8
Reason Not Completed
Adverse Event             0             0             0             4             0             1
Lost to Follow-up             0             0             0             2             1             1
Withdrawal by Subject             0             0             0             1             0             1
OTHER             0             0             0             0             0             2
Lack of Efficacy             0             0             0             2             2             3
Protocol Violation             0             0             0             2             1             0
[1]
26 of 27 double-blind placebo completers and 4 of 8 placebo non-completers entered open-label.
[2]
24 of 25 double-blind RIS low dose completers and 0 RIS low dose non-completers entered open-label.
[3]
All 25 double-blind RIS high dose completers and 0 RIS high dose non-completers entered open-label.
Arm/Group Title Placebo Risperidone Low Dose Risperidone High Dose Total
Hide Arm/Group Description Double-blind Period. Oral solution for 6 weeks. Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks. Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks. Total of all reporting groups
Overall Number of Baseline Participants 35 30 31 96
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 30 participants 31 participants 96 participants
<=18 years
35
 100.0%
30
 100.0%
31
 100.0%
96
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 30 participants 31 participants 96 participants
8.6  (2.57) 10.2  (3.42) 9.3  (3.11) 9.3  (3.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 30 participants 31 participants 96 participants
Female
4
  11.4%
5
  16.7%
3
   9.7%
12
  12.5%
Male
31
  88.6%
25
  83.3%
28
  90.3%
84
  87.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States of America Number Analyzed 35 participants 30 participants 31 participants 96 participants
35 30 31 96
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 30 participants 31 participants 96 participants
<12 years 30 20 24 74
>=12 years 5 10 7 22
1.Primary Outcome
Title Change in Aberrant Behavior Checklist Irritability (ABC-I) Subscale
Hide Description Measure of irritability symptoms of autism. Score range 0 to 45 (lower score = lesser severity).
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).
Arm/Group Title Placebo Risperidone Low Dose Risperidone High Dose
Hide Arm/Group Description:
Double-blind Period. Oral solution for 6 weeks.
Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
Overall Number of Participants Analyzed 34 29 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.5  (10.67) -7.4  (8.12) -12.4  (6.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risperidone High Dose
Comments

A step-down testing procedure was employed with the risperidone high dose versus placebo comparison tested first. If this comparison was significant the risperidone low dose versus placebo comparison would be performed.

A clinically relevant difference in the change from baseline on the ABC Irritability subscale was assumed to be 6 with a standard deviation of 8. To achieve 80% power with Type I error rate of 5%, 93 subjects were required.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Type I error is preserved by the step down procedure, no multiple comparison adjustment is needed. A priori threshold for statistical significance was 0.05.
Method ANCOVA
Comments ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline ABC-I value
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.9
Confidence Interval (2-Sided) 95%
-12.19 to -3.52
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.18
Estimation Comments Mean difference is change in Risperidone high dose arm minus change in placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Risperidone Low Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments Type I error is preserved by the step down procedure, no multiple comparison adjustment is needed. A priori threshold for statistical significance was 0.05.
Method ANCOVA
Comments ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline ABC-I value
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-7.36 to 1.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.17
Estimation Comments Mean difference is change in Risperidone low dose arm minus change in placebo arm.
2.Secondary Outcome
Title Number of Participants Who Had at Least 25% Improvement in ABC-I
Hide Description ABC-I is a measure of irritability symptoms of autism with score range 0 to 45 (lower score = lesser severity).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).
Arm/Group Title Placebo Risperidone Low Dose Risperidone High Dose
Hide Arm/Group Description:
Double-blind Period. Oral solution for 6 weeks.
Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
Overall Number of Participants Analyzed 34 29 29
Measure Type: Number
Unit of Measure: participants
14 15 24
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risperidone High Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments P-value is not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Risperidone Low Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.817
Comments P-value is not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.
3.Secondary Outcome
Title Change in Clinical Global Impression Severity (CGI-S)
Hide Description Investigator evaluation of severity of illness and functional impairment on a 7-point scale (1="not ill", 2="very mild", 3="mild", 4="moderate", 5="marked", 6="severe", 7="extremely severe").
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).
Arm/Group Title Placebo Risperidone Low Dose Risperidone High Dose
Hide Arm/Group Description:
Double-blind Period. Oral solution for 6 weeks.
Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
Overall Number of Participants Analyzed 34 29 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.3  (0.79) -0.4  (0.73) -1.0  (0.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risperidone High Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is not adjusted for multiple comparisons.
Method ANCOVA
Comments ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline CGI-S value.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.02 to -0.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.17
Estimation Comments Mean difference is change in Risperidone high dose arm minus change in placebo arm.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Risperidone Low Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.769
Comments P-value is not adjusted for multiple comparisons.
Method ANCOVA
Comments ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline CGI-S value
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.39 to 0.29
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.17
Estimation Comments Mean difference is change in Risperidone low dose arm minus change in placebo arm.
4.Secondary Outcome
Title Number of Participants Who Had Clinical Global Impression Change Ratings of Much or Very Much Improved.
Hide Description Investigator impression of change over time from double-blind baseline on a 7-point scale (1="very much improved", 2="much improved", 3="minimally improved", 4="no change", 5="minimally worse", 6="much worse", 7="very much worse").
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects with at least one dose of study medication and at least one postbaseline value. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).
Arm/Group Title Placebo Risperidone Low Dose Risperidone High Dose
Hide Arm/Group Description:
Double-blind Period. Oral solution for 6 weeks.
Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
Overall Number of Participants Analyzed 34 30 30
Measure Type: Number
Unit of Measure: participants
5 5 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risperidone High Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Risperidone Low Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.985
Comments P-value is not adjusted for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.
5.Secondary Outcome
Title Change in Fasting Glucose (mg/dL) at 6 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects with at least one dose of study medication and both baseline and at least one postbaseline fasting laboratory samples. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period (Last Observation Carried Forward [LOCF]).
Arm/Group Title Placebo Risperidone Low Dose Risperidone High Dose
Hide Arm/Group Description:
Double-blind Period. Oral solution for 6 weeks.
Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
Overall Number of Participants Analyzed 22 23 23
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.4  (8.20) -0.1  (8.81) -0.3  (9.74)
6.Secondary Outcome
Title Change in Insulin Resistance (IR) at 6 Weeks
Hide Description Insulin resistance calculated using the homeostatic model assessment 1 (HOMA1)formula: fasting glucose (mmol/L) times fasting insulin (uU/L) divided by 22.5. HOMA-IR is a widely used clinical tool for estimating insulin resistance based upon the balance between glucose output and insulin secretion. Normal values should be close to 1, while an increase indicates a decrease in insulin sensitivity (or increase in insulin resistance), a potential predictor for the development of Type 2 Diabetes Mellitus.
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects with >=1 dose of study medication and fasting glucose and insulin at baseline and at >=1 postbaseline time point. For subjects who discontinued, Week 6 data is imputed using the subject's last nonmissing, postbaseline value in the double-blind period. Means are adjusted for baseline weight (<45 kg, >=45 kg) and baseline IR.
Arm/Group Title Placebo Risperidone Low Dose Risperidone High Dose
Hide Arm/Group Description:
Double-blind Period. Oral solution for 6 weeks.
Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
Overall Number of Participants Analyzed 22 21 22
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.36
(-0.34 to 1.07)
-0.10
(-0.76 to 0.55)
0.45
(-0.18 to 1.08)
7.Secondary Outcome
Title Change in Fasting Glucose (mg/dL) at 6 Months
Hide Description [Not Specified]
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with at least one dose of study medication in the open label phase and both double-blind baseline and at least one open-label period fasting laboratory samples. For subjects who discontinued, Month 6 data is imputed using the subject's last nonmissing, postbaseline value in the open-label period.
Arm/Group Title Placebo/RIS Ris Low Dose/RIS Ris High Dose/RIS
Hide Arm/Group Description:
Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
Overall Number of Participants Analyzed 19 16 16
Mean (Standard Deviation)
Unit of Measure: mg/dL
4.0  (12.27) 3.5  (12.26) 2.3  (8.70)
8.Secondary Outcome
Title Change in Insulin Resistance (IR) at 6 Months
Hide Description Insulin resistance calculated using the homeostatic model assessment 1 (HOMA1) formula: fasting glucose (mmol/L) times fasting insulin (uU/L) divided by 22.5. HOMA-IR is a widely used clinical tool for estimating insulin resistance based upon the balance between glucose output and insulin secretion. Normal values should be close to 1, while an increase indicates a decrease in insulin sensitivity (or increase in insulin resistance), a potential predictor for the development of Type 2 Diabetes Mellitus.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with at least one dose of study medication in the open label phase and both double-blind baseline and at least one open-label period fasting laboratory samples. For subjects who discontinued, Month 6 data is imputed using the subject's last nonmissing, postbaseline value in the open-label period.
Arm/Group Title Placebo/RIS Ris Low Dose/RIS Ris High Dose/RIS
Hide Arm/Group Description:
Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
Overall Number of Participants Analyzed 19 16 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.09  (2.67) 0.36  (0.89) 0.75  (0.91)
Time Frame Double-blind period: 6 weeks. Open-label period: 6 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Risperidone Low Dose Risperidone High Dose Open-label Risperidone
Hide Arm/Group Description Double-blind Period. Oral solution for 6 weeks. Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks. Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks. Subjects who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
All-Cause Mortality
Placebo Risperidone Low Dose Risperidone High Dose Open-label Risperidone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Risperidone Low Dose Risperidone High Dose Open-label Risperidone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/35 (2.86%)   0/30 (0.00%)   0/31 (0.00%)   1/79 (1.27%) 
Congenital, familial and genetic disorders         
Hydrocele * 1  0/35 (0.00%)  0/30 (0.00%)  0/31 (0.00%)  1/79 (1.27%) 
Psychiatric disorders         
Aggression * 1  1/35 (2.86%)  0/30 (0.00%)  0/31 (0.00%)  0/79 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Risperidone Low Dose Risperidone High Dose Open-label Risperidone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/35 (57.14%)   12/30 (40.00%)   27/31 (87.10%)   39/79 (49.37%) 
Gastrointestinal disorders         
Abdominal discomfort * 1  3/35 (8.57%)  0/30 (0.00%)  0/31 (0.00%)  2/79 (2.53%) 
Abdominal pain upper * 1  0/35 (0.00%)  1/30 (3.33%)  2/31 (6.45%)  1/79 (1.27%) 
Constipation * 1  1/35 (2.86%)  0/30 (0.00%)  2/31 (6.45%)  3/79 (3.80%) 
Nausea * 1  1/35 (2.86%)  1/30 (3.33%)  2/31 (6.45%)  0/79 (0.00%) 
Vomiting * 1  2/35 (5.71%)  2/30 (6.67%)  2/31 (6.45%)  7/79 (8.86%) 
Diarrhea * 1  1/35 (2.86%)  1/30 (3.33%)  0/31 (0.00%)  4/79 (5.06%) 
General disorders         
Pyrexia * 1  0/35 (0.00%)  0/30 (0.00%)  2/31 (6.45%)  6/79 (7.59%) 
Thirst * 1  0/35 (0.00%)  0/30 (0.00%)  2/31 (6.45%)  0/79 (0.00%) 
Fatigue * 1  0/35 (0.00%)  0/30 (0.00%)  1/31 (3.23%)  4/79 (5.06%) 
Infections and infestations         
Ear infection * 1  0/35 (0.00%)  0/30 (0.00%)  2/31 (6.45%)  1/79 (1.27%) 
Nasopharyngitis * 1  2/35 (5.71%)  2/30 (6.67%)  4/31 (12.90%)  5/79 (6.33%) 
Upper respiratory tract infection * 1  1/35 (2.86%)  1/30 (3.33%)  3/31 (9.68%)  6/79 (7.59%) 
Investigations         
Weight increased * 1  2/35 (5.71%)  3/30 (10.00%)  4/31 (12.90%)  7/79 (8.86%) 
Metabolism and nutrition disorders         
Increased appetite * 1  2/35 (5.71%)  5/30 (16.67%)  11/31 (35.48%)  9/79 (11.39%) 
Nervous system disorders         
Akathisia * 1  1/35 (2.86%)  0/30 (0.00%)  2/31 (6.45%)  0/79 (0.00%) 
Headache * 1  4/35 (11.43%)  2/30 (6.67%)  2/31 (6.45%)  4/79 (5.06%) 
Hypersomnia * 1  1/35 (2.86%)  0/30 (0.00%)  2/31 (6.45%)  0/79 (0.00%) 
Psychomotor hyperactivity * 1  2/35 (5.71%)  1/30 (3.33%)  1/31 (3.23%)  1/79 (1.27%) 
Sedation * 1  0/35 (0.00%)  1/30 (3.33%)  8/31 (25.81%)  6/79 (7.59%) 
Somnolence * 1  1/35 (2.86%)  0/30 (0.00%)  7/31 (22.58%)  4/79 (5.06%) 
Psychiatric disorders         
Aggression * 1  2/35 (5.71%)  0/30 (0.00%)  0/31 (0.00%)  2/79 (2.53%) 
Agitation * 1  2/35 (5.71%)  0/30 (0.00%)  1/31 (3.23%)  3/79 (3.80%) 
Depression * 1  0/35 (0.00%)  0/30 (0.00%)  2/31 (6.45%)  0/79 (0.00%) 
Insomnia * 1  2/35 (5.71%)  0/30 (0.00%)  0/31 (0.00%)  3/79 (3.80%) 
Renal and urinary disorders         
Enuresis * 1  0/35 (0.00%)  2/30 (6.67%)  2/31 (6.45%)  4/79 (5.06%) 
Respiratory, thoracic and mediastinal disorders         
Epistaxis * 1  0/35 (0.00%)  0/30 (0.00%)  2/31 (6.45%)  0/79 (0.00%) 
Cough * 1  0/35 (0.00%)  0/30 (0.00%)  0/31 (0.00%)  4/79 (5.06%) 
Skin and subcutaneous tissue disorders         
Rash * 1  0/35 (0.00%)  2/30 (6.67%)  0/31 (0.00%)  3/79 (3.80%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
Results Point of Contact
Name/Title: Clinical Leader
Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phone: 609 730 2317
Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00576732     History of Changes
Other Study ID Numbers: CR014740
RISAUT4002
First Submitted: December 17, 2007
First Posted: December 19, 2007
Results First Submitted: September 2, 2010
Results First Posted: September 28, 2010
Last Update Posted: May 9, 2014