Status:
COMPLETED
Long-acting Injectable Risperidone in Patients With Schizophrenia After an Acute Episode
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The primary objective of this randomized trial was to investigate whether early initiation of treatment with Risperdal Consta after an acute episode was not inferior to the routine approach (oral trea...
Detailed Description
Although many schizophrenia patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regiment. Long-acting injectable f...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia by criteria of Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV)
- acute episode of schizophrenia within 2 weeks of study entry
- o subjects currently not treated or treated with oral antipsychotics or short-acting injectable antipsychotics (zuclopenthixol acutard is allowed) at doses not exceeding the registered dose
- Positive And Negative Syndrome Scale (PANSS) score \>=80
- Clinical Global Impression - Severity (CGI-S) score \>=5
Exclusion
- DSM-IV axis I diagnosis other than schizophrenia
- known hypersensitivity or lack of response to risperidone
- pregnant or nursing females, or those without adequate contraception
- alcohol or drug abuse or dependence diagnosed in the last month prior to entry,
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00216671
Start Date
November 1 2005
End Date
December 1 2009
Last Update
July 19 2013
Active Locations (31)
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1
Copenhagen, Denmark
2
Glostrup Municipality, Denmark
3
Hjørring, Denmark
4
Kolding, Denmark