Status:
COMPLETED
A Trial Comparing Risperidone Long-Acting Injection With Oral Antipsychotic in the Treatment of Early Psychosis
Lead Sponsor:
Janssen-Ortho Inc., Canada
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-30 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the effectiveness, safety and tolerability of risperidone long-acting injection (LAI) versus oral antipsychotics in participants with recent onset psychosis (a...
Detailed Description
This is an open-label (all people know identity of intervention), randomized (the study drug is assigned by chance), multicenter (conducted in more than 1 center), and exploratory study in participant...
Eligibility Criteria
Inclusion
- In-patients or out-patients
- Primary Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnosis of schizophrenia, schizophreniform disorder or schizoaffective disorder for no longer than 3 years after diagnosis and treatment of a psychotic illness
- Positive and Negative Syndrome Scale (PANSS) score of 60-120 at Visit 1 and 2
- Currently on monotherapy atypical antipsychotic treatment below local label guidelines or treatment naive
- Able to complete self-assessments in either English or French
Exclusion
- Current primary Axis-1 diagnosis other than schizophrenia, schizophreniform disorder or schizoaffective disorder, according to DSM-IV
- Current drug or alcohol dependence
- Treatment with a depot antipsychotic within 3 months of study start
- Confirmed or suspected history of lack of tolerability, hypersensitivity or allergy to risperidone
- Risperidone non-responders (based on evidence of adequate trial of treatment)
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00246259
Start Date
October 1 2004
End Date
December 1 2008
Last Update
December 11 2013
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Calgary, Alberta, Canada
2
Edmonton, Alberta, Canada
3
Victoria, British Columbia, Canada
4
Dartmouth, Nova Scotia, Canada