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Trial record 37 of 53 for:    Developmental Disabilities | ( Map: Indiana, United States )

A Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children

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ClinicalTrials.gov Identifier: NCT01050582
Recruitment Status : Completed
First Posted : January 15, 2010
Results First Posted : November 27, 2012
Last Update Posted : November 27, 2012
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Type Interventional
Study Design Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Schizophrenia
Bipolar Disorder
Autistic Disorder
Conduct and Other Disruptive Behavior Disorders
Interventions Drug: Risperidone
Drug: Other atypical antipsychotic drugs
Enrollment 244
Recruitment Details A total of 244 subjects were assessed for eligibility of whom 230 signed informed consent. Of the 230, 43 were found not to meet inclusion or exclusion criteria, 2 withdrew consent, and 1 was not kept in the study due to a site decision. A total of 184 subjects were included in the analysis.
Pre-assignment Details  
Arm/Group Title Risperidone Other Atypical Antipsychotics
Hide Arm/Group Description Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
Period Title: Overall Study
Started 133 51
Completed 133 51
Not Completed 0 0
Arm/Group Title Risperidone Other Atypical Antipsychotics Total
Hide Arm/Group Description Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment Total of all reporting groups
Overall Number of Baseline Participants 133 51 184
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 133 participants 51 participants 184 participants
12  (2.5) 12  (2.5) 12  (2.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 51 participants 184 participants
Female
16
  12.0%
18
  35.3%
34
  18.5%
Male
117
  88.0%
33
  64.7%
150
  81.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 51 participants 184 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.8%
1
   2.0%
2
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
12
   9.0%
6
  11.8%
18
   9.8%
White
110
  82.7%
36
  70.6%
146
  79.3%
More than one race
3
   2.3%
1
   2.0%
4
   2.2%
Unknown or Not Reported
7
   5.3%
7
  13.7%
14
   7.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 133 participants 51 participants 184 participants
United States 59 40 99
Germany 41 6 47
Poland 19 3 22
Netherlands 8 0 8
Greece 3 2 5
Belgium 3 0 3
1.Primary Outcome
Title Height (cm) Z-score at Study Visit
Hide Description Height (cm) measured at the study visit was converted to a Z-score based on the US Center for Disease Control 2000 growth charts for US subjects and European growth charts for ex-US subjects. A z-score indicates how many standard deviations a subject is away from the expected height for the subject's age and gender.
Time Frame One single study visit, approximately one week after informed consent has been obtained
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with a height assessment available at the study visit.
Arm/Group Title Risperidone Other Atypical Antipsychotics
Hide Arm/Group Description:
Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
Overall Number of Participants Analyzed 132 50
Mean (Standard Deviation)
Unit of Measure: z-score
0.40  (1.189) 0.09  (1.079)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risperidone, Other Atypical Antipsychotics
Comments Null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in current height z-score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Linear
Comments Covariates: weight (wt) divided expected wt for age and height (ht), age, use of concomitant medication with growth effects, preexposure ht z-score.
Method of Estimation Estimation Parameter Slope
Estimated Value 0.447
Confidence Interval (2-Sided) 95%
0.220 to 0.674
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.116
Estimation Comments Slope associated with treatment dummy variable with 1 indicating risperidone and 0 indicating other atypical antipychotics.
2.Secondary Outcome
Title Age (Years) at Current Tanner Stage
Hide Description Tanner stage is an evaluation of pubertal development with values ranging from 1 (pre-pubertal) to 5 (adult). A standardized, validated tool containing standardized pictures and written descriptions of the stages of pubic hair development, breast development for girls, and genital development for boys was used by physicians to make their assessment.
Time Frame One single study visit, approximately one week after informed consent has been obtained
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a physician assessed Tanner stage value.
Arm/Group Title Risperidone Other Atypical Antipsychotics
Hide Arm/Group Description:
Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
Overall Number of Participants Analyzed 124 49
Mean (Standard Deviation)
Unit of Measure: years
Tanner Stage 1 10.2  (1.31) 10.3  (1.78)
Tanner Stage 2 11.3  (1.68) 11.2  (1.73)
Tanner Stage 3 13.1  (2.18) 12.2  (1.21)
Tanner Stage 4 14.9  (1.27) 15.0  (1.46)
Tanner Stage 5 15.1  (0.69) 15.0  (1.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risperidone, Other Atypical Antipsychotics
Comments The null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in age (years) at current Tanner stage.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.378
Comments [Not Specified]
Method Regression, Linear
Comments Covariates: Tanner stage and gender
Method of Estimation Estimation Parameter Slope
Estimated Value -0.221
Confidence Interval (2-Sided) 95%
-0.711 to 0.269
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.250
Estimation Comments Slope associated with treatment dummy variable with 1 indicating risperidone and 0 indicating other atypical antipsychotics.
3.Secondary Outcome
Title Number of Participants With Retrospectively Reported Potentially Prolactin-Related Adverse Events
Hide Description Previous potentially prolactin-related adverse events, including hyperprolactinemia, were reviewed and abstracted from participants' medical records. Potentially prolactin-related adverse events include breast symptoms, menstrual disorders, hyperprolactinemia, and prolactinoma.
Time Frame Retrospectively during the time of exposure for up to 2 years prior to the study visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Risperidone Other Atypical Antipsychotics
Hide Arm/Group Description:
Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
Overall Number of Participants Analyzed 133 51
Measure Type: Number
Unit of Measure: participants
7 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risperidone, Other Atypical Antipsychotics
Comments Null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in frequency of retrospectively reported potentially prolactin-related adverse events
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.999
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.865
Confidence Interval 95%
0.189 to 3.963
Estimation Comments Estimated OR is from a logistic regression model including factors for treatment arm, age, indication, and use of concomitant medication with growth effects.
Time Frame Days from signing of informed consent to study visit
Adverse Event Reporting Description Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.
 
Arm/Group Title Risperidone Other Atypical Antipsychotics
Hide Arm/Group Description Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
All-Cause Mortality
Risperidone Other Atypical Antipsychotics
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Risperidone Other Atypical Antipsychotics
Affected / at Risk (%) Affected / at Risk (%)
Total   0/133 (0.00%)   0/51 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Risperidone Other Atypical Antipsychotics
Affected / at Risk (%) Affected / at Risk (%)
Total   8/133 (6.02%)   3/51 (5.88%) 
Gastrointestinal disorders     
Nausea * 1  1/133 (0.75%)  0/51 (0.00%) 
General disorders     
Fatigue * 1  1/133 (0.75%)  1/51 (1.96%) 
Drug ineffective * 1  1/133 (0.75%)  0/51 (0.00%) 
Oedema * 1  1/133 (0.75%)  0/51 (0.00%) 
Infections and infestations     
Eye infection * 1  1/133 (0.75%)  0/51 (0.00%) 
Lower respiratory tract infection * 1  0/133 (0.00%)  1/51 (1.96%) 
Nasopharyngitis * 1  0/133 (0.00%)  1/51 (1.96%) 
Investigations     
Blood prolactin increased * 1  1/133 (0.75%)  0/51 (0.00%) 
Weight increased * 1  1/133 (0.75%)  0/51 (0.00%) 
Metabolism and nutrition disorders     
Obesity * 1  1/133 (0.75%)  0/51 (0.00%) 
Nervous system disorders     
Sedation * 1  1/133 (0.75%)  0/51 (0.00%) 
Headache * 1  1/133 (0.75%)  0/51 (0.00%) 
Psychiatric disorders     
Middle insomnia * 1  1/133 (0.75%)  0/51 (0.00%) 
Reproductive system and breast disorders     
Breast pain * 1  0/133 (0.00%)  1/51 (1.96%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
A total of 350 subjects in a 1:1 ratio between the two arms was planned. Recruitment difficulties led to an imbalance in the number of subjects per arm and to early termination of the study. The results should be interpreted within this context.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Clinical Leader
Organization: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Phone: 609-730-6581
Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01050582     History of Changes
Other Study ID Numbers: CR016687
RISNAP4022 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
First Submitted: January 14, 2010
First Posted: January 15, 2010
Results First Submitted: July 26, 2012
Results First Posted: November 27, 2012
Last Update Posted: November 27, 2012