Status:
COMPLETED
A Pharmacokinetic and Safety Study of Risperidone Long Acting Injectable in Schizophrenic Patients
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Schizophrenia
Eligibility:
All Genders
20-64 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to explore the pharmacokinetic profile and safety after biweekly (every 2-week) intramuscular (IM) injections (6 injections) of risperidone long acting injectable 25, 37.5...
Detailed Description
This is an open-label, multicenter, randomized, 3-arm trial to compare the pharmacokinetic profile and the safety profile between 3 dose groups. There are 2 periods in this study: a 10-week treatment ...
Eligibility Criteria
Inclusion
- Japanese patients with a DSM-IV diagnosis of schizophrenia
- A Positive and Negative Syndrome Scale (PANSS) total score between 60 (included) and 120 (excluded)
- In- or out-patients (change of institutionalization status during the trial period is allowed).
Exclusion
- No DSM-IV diagnosis other than schizophrenia
- No convulsive disorders such as epilepsy
- No neuroleptic malignant syndrome or physical fatigue associated with dehydration, malnutrition
- No present illness or history of diabetes or risks of diabetes such as hyperglycemia and obesity
- No hemorrhagic diathesis.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2003
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00653406
Start Date
November 1 2002
End Date
October 1 2003
Last Update
May 17 2011
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