An Observational 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.

First Received on January 14, 2010. Last Updated on April 27, 2012 History of Changes

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT01050582

Purpose

The purpose of this observational study is to evaluate risk of prolactin-related adverse events (side effects) and the effects of risperidone compared with other atypical antipsychotic drugs on the physical maturity, growth and development of children exposed to these drugs

Condition	Intervention	Phase
Schizophrenia Bipolar Disorder Autistic Disorder Attention Deficit and Disruptive Behavior Disorders	Drug: Risperidone Drug: Other atypical antipsychotic drugs	Phase 4

Study Type:	Interventional
Official Title:	Evaluation of Growth, Sexual Maturation, and Prolactin-Related Adverse Events in the Pediatric Population Exposed to Atypical Antipsychotic Drugs

Resource links provided by NLM:

MedlinePlus related topics: Autism Bipolar Disorder Schizophrenia

Drug Information available for: Prolactin Risperidone

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

To compare Z-scores for height, age at current Tanner stage, and prolactin-related adverse events between patients exposed to risperidone and patients exposed to other atypical antipsychotic drugs. [ Time Frame: During the study visit and retrospectively during the time of exposure for up to 2 years prior to the study visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assess the prolactin value and risk of hyperprolactinemia associated with risperidone as compared with other atypical antipsychotic medications in a pediatric population. [ Time Frame: One time during the study visit ] [ Designated as safety issue: Yes ]
Identification of subgroups of patients at high risk for changes in height or maturation. [ Time Frame: During the study visit and retrospectively during the time of exposure for up to 2 years prior to the study visit ] [ Designated as safety issue: No ]

Enrollment:	244
Study Start Date:	October 2009
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 001 Risperidone As per local prescribing practices	Drug: Risperidone As per local prescribing practices
No Intervention: 002 Other atypical antipsychotic drugs As per local prescribing practices	Drug: Other atypical antipsychotic drugs As per local prescribing practices

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Eligibility

Ages Eligible for Study:	8 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

One or both parents (according to local regulations) or a guardian must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study (If appropriate according to local regulations, the patient must also assent)
Treated for schizophrenia, bipolar mania, autistic disorder, or conduct and other disruptive behavior disorders
Had at least 6 months of exposure for an atypical antipsychotic drug within 24 months before the study visit (patients may or may not be taking the atypical antipsychotics at the time of actual enrollment, eligible patients can have exposure to multiple atypical antipsychotics, however, they cannot concomitantly be exposed to more than 1 atypical antipsychotic for a period of greater than 30 days)
Had medical records or automated data available for at least 1 year prior to the start of exposure
Height and weight were recorded at least once within 1 year before the start of exposure, and if available at any time points after the start of exposure in the medical records or electronic databases (not mandatory)

Exclusion Criteria:

Have at least 1 medical record, at any time before the start of exposure, consistent with malignancy (other than non-melanoma skin cancer), pregnancy, or a developmental delay or abnormality associated with growth or sexual maturation delays not related to the specified indications
Had exposure to prolactin elevating medications other than atypical antipsychotics and selective serotonin reuptake inhibitors (SSRIs)
Had exposure to Paliperidone
Cannot comply with study procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050582

Show 29 Study Locations

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

Additional Information:

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Clinical Leader Psychiatry, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT01050582 History of Changes
Other Study ID Numbers:	CR016687
Study First Received:	January 14, 2010
Last Updated:	April 27, 2012
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Schizophrenia
Bipolar Disorder
Autistic Disorder
Attention Deficit and Disruptive Behavior Disorders
Risperidone

RISPERDAL
Antipsychotic Agents
Prolactin
Pediatrics

Additional relevant MeSH terms:

Autistic Disorder
Mental Disorders
Bipolar Disorder
Attention Deficit and Disruptive Behavior Disorders
Schizophrenia
Attention Deficit Disorder with Hyperactivity
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Affective Disorders, Psychotic
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Risperidone

Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 23, 2012