The Efficacy and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00034749
• Date of registration: 02/05/2002
• Prospective Registration: No
• Primary sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Public title: The Efficacy and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia
• Scientific title: The Efficacy and Safety of Risperidone in Adolescents With Schizophrenia: a Comparison of Two Dose Ranges of Risperidone
• Date of first enrolment: April 2001
• Target sample size: 279
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00034749
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Belgium, Bulgaria, Czech Republic, Estonia, Germany, Poland, Switzerland, United States

Contacts

• Name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
• Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects will be eligible for study enrollment if they: are adolescents between the
ages of 13 and 17 years

- have a confirmed diagnosis of schizophrenia and are suffering from an acute episode

- provide their assent and parental informed consent to participate

- are otherwise relatively healthy on the basis of a medical and physical examination

- and are able to be in-patients for approximately 2 weeks.

Exclusion Criteria:

- Subjects will be excluded from the study if they: meet the criteria for psychiatric
disorders other than schizophrenia

- have moderate or severe mental retardation

- fail to respond to treatment with at least two typical or atypical antipsychotics

- have a history of substance dependence within the 3 months before screening

- are considered at risk for suicidal or violent behavior

- have a seizure disorder

- have a history of neuroleptic malignant syndrome, similar encephalopathic syndrome,
or tardive dyskinesia

- or receive prohibited medication within a specified period before screening.



Age minimum: 13 Years
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Risperidone

Primary Outcome(s)

Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 8-week endpoint

Secondary Outcome(s)

Change from baseline in PANSS subscale scores and Clinical Global Impression (CGI-S and CGI-I) scores, number of subjects achieving a clinical response (at least 20% improvement in total PANSS), safety, tolerability and pharmacokinetics.

Secondary ID(s)

CR003361

Source(s) of Monetary Support

Please refer to primary and secondary sponsors