Trial Outcomes & Findings for 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 (NCT NCT01050582)

Last Updated: 2012-11-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

244 participants

Primary outcome timeframe

One single study visit, approximately one week after informed consent has been obtained

Results posted on

2012-11-27

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	133	51
Overall Study COMPLETED	133	51
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Risperidone n=133 Participants Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment	Other Atypical Antipsychotics n=51 Participants 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 n=184 Participants Total of all reporting groups
Age Continuous	12 years STANDARD_DEVIATION 2.5 • n=5 Participants	12 years STANDARD_DEVIATION 2.5 • n=7 Participants	12 years STANDARD_DEVIATION 2.5 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	117 Participants n=5 Participants	33 Participants n=7 Participants	150 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	110 Participants n=5 Participants	36 Participants n=7 Participants	146 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	59 participants n=5 Participants	40 participants n=7 Participants	99 participants n=5 Participants
Region of Enrollment Germany	41 participants n=5 Participants	6 participants n=7 Participants	47 participants n=5 Participants
Region of Enrollment Poland	19 participants n=5 Participants	3 participants n=7 Participants	22 participants n=5 Participants
Region of Enrollment Netherlands	8 participants n=5 Participants	0 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Greece	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Belgium	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: One single study visit, approximately one week after informed consent has been obtained

Population: All participants with a height assessment available at the study visit.

Outcome measures

Outcome measures
Measure	Risperidone n=132 Participants Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment	Other Atypical Antipsychotics n=50 Participants 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
Height (cm) Z-score at Study Visit	0.40 z-score Standard Deviation 1.189	0.09 z-score Standard Deviation 1.079

SECONDARY outcome

Timeframe: One single study visit, approximately one week after informed consent has been obtained

Population: Participants with a physician assessed Tanner stage value.

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.

Outcome measures

Outcome measures
Measure	Risperidone n=124 Participants Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment	Other Atypical Antipsychotics n=49 Participants 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
Age (Years) at Current Tanner Stage Tanner Stage 1	10.2 years Standard Deviation 1.31	10.3 years Standard Deviation 1.78
Age (Years) at Current Tanner Stage Tanner Stage 2	11.3 years Standard Deviation 1.68	11.2 years Standard Deviation 1.73
Age (Years) at Current Tanner Stage Tanner Stage 3	13.1 years Standard Deviation 2.18	12.2 years Standard Deviation 1.21
Age (Years) at Current Tanner Stage Tanner Stage 4	14.9 years Standard Deviation 1.27	15.0 years Standard Deviation 1.46
Age (Years) at Current Tanner Stage Tanner Stage 5	15.1 years Standard Deviation 0.69	15.0 years Standard Deviation 1.82

SECONDARY outcome

Timeframe: Retrospectively during the time of exposure for up to 2 years prior to the study visit

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.

Outcome measures

Outcome measures
Measure	Risperidone n=133 Participants Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment	Other Atypical Antipsychotics n=51 Participants 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
Number of Participants With Retrospectively Reported Potentially Prolactin-Related Adverse Events	7 participants	3 participants

Adverse Events

Risperidone

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Other Atypical Antipsychotics

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Risperidone n=133 participants at risk Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment	Other Atypical Antipsychotics n=51 participants at risk 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
Investigations Blood prolactin increased	0.75% 1/133 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.	0.00% 0/51 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.
Infections and infestations Eye infection	0.75% 1/133 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.	0.00% 0/51 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.
Nervous system disorders Sedation	0.75% 1/133 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.	0.00% 0/51 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.
General disorders Fatigue	0.75% 1/133 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.	2.0% 1/51 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.
Reproductive system and breast disorders Breast pain	0.00% 0/133 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.	2.0% 1/51 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.
Nervous system disorders Headache	0.75% 1/133 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.	0.00% 0/51 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.
Infections and infestations Lower respiratory tract infection	0.00% 0/133 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.	2.0% 1/51 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.
Infections and infestations Nasopharyngitis	0.00% 0/133 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.	2.0% 1/51 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.
Psychiatric disorders Middle insomnia	0.75% 1/133 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.	0.00% 0/51 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.
Investigations Weight increased	0.75% 1/133 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.	0.00% 0/51 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.
Gastrointestinal disorders Nausea	0.75% 1/133 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.	0.00% 0/51 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.
General disorders Drug ineffective	0.75% 1/133 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.	0.00% 0/51 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.
Metabolism and nutrition disorders Obesity	0.75% 1/133 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.	0.00% 0/51 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.
General disorders Oedema	0.75% 1/133 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.	0.00% 0/51 • Days from signing of informed consent to study visit Adverse events prospectively reported from the time of signing informed consent to the study visit are summarized.

Additional Information

Clinical Leader

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

Phone: 609-730-6581

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place