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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01050582
First received: January 14, 2010
Last updated: October 26, 2012
Last verified: October 2012
Results First Received: July 26, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Risperidone Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
Other Atypical Antipsychotics 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

Participant Flow:   Overall Study
    Risperidone     Other Atypical Antipsychotics  
STARTED     133     51  
COMPLETED     133     51  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Risperidone Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
Other Atypical Antipsychotics 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 Total of all reporting groups

Baseline Measures
    Risperidone     Other Atypical Antipsychotics     Total  
Number of Participants  
[units: participants]
  133     51     184  
Age  
[units: years]
Mean ± Standard Deviation
  12  ± 2.5     12  ± 2.5     12  ± 2.5  
Gender  
[units: participants]
     
Female     16     18     34  
Male     117     33     150  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     1     2  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     12     6     18  
White     110     36     146  
More than one race     3     1     4  
Unknown or Not Reported     7     7     14  
Region of Enrollment  
[units: 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  



  Outcome Measures
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1.  Primary:   Height (cm) Z-score at Study Visit   [ Time Frame: One single study visit, approximately one week after informed consent has been obtained ]

2.  Secondary:   Age (Years) at Current Tanner Stage   [ Time Frame: One single study visit, approximately one week after informed consent has been obtained ]

3.  Secondary:   Number of Participants With Retrospectively Reported Potentially Prolactin-Related Adverse Events   [ Time Frame: Retrospectively during the time of exposure for up to 2 years prior to the study visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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.


  More Information
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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


No publications provided


Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01050582     History of Changes
Other Study ID Numbers: CR016687, RISNAP4022
Study First Received: January 14, 2010
Results First Received: July 26, 2012
Last Updated: October 26, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration