Status:
COMPLETED
Investigate Risperidone for the Treatment of Schizophrenia in Adolescents
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
13-17 years
Phase:
PHASE3
Brief Summary
A clinical study to evaluate the efficacy, safety and tolerability of two dose ranges of risperidone (1 to 3 mg/day, and 4 to 6 mg/day) versus placebo (an inactive substance like a sugar pill) in adol...
Detailed Description
Subjects will be aged 13 to 17 years with a diagnosis of schizophrenia. On enrollment, subjects will be assigned to receive 1 of 3 treatments (oral placebo tablets, oral risperidone tablets 1 to 3 mg,...
Eligibility Criteria
Inclusion
- A responsible person must be available to accompany the subject to the site at each visit
- patient must meet the DSM-IV criteria for schizophrenia
Exclusion
- Patients with mild, moderate or severe mental retardation
- patients with a known or suspected history of substance dependence
- subjects weighing \<35kg
- subjects who cannot swallow oral tablets
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00088075
Start Date
August 1 2004
End Date
December 1 2005
Last Update
June 8 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.