Status:
COMPLETED
Treatment With Risperidone Long Acting Injectable (RLAI) in an Early Phase of Psychosis
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Schizophrenia
Psychotic Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this research study is to see how well patients in an early phase of their illness respond to treatment and whether this depends on how well they functioned socially, academically and v...
Detailed Description
Intervention with antipsychotic medications during the early stages of schizophrenia may result in a better outcome for patients, with a higher number of patients achieving full remission, a shorter t...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia/schizoaffective disorder for no longer than 2 years
- At least 2 previous psychotic episodes
- At least 6 months of antipsychotic treatment required
- maximum total Positive and Negative Symptom Score (PANSS) score of \< = 80
- Patients may be currently treated with any antipsychotic (with the exception of clozapine and depot neuroleptics) at doses not exceeding the registered highest recommended dose.
Exclusion
- Already on treatment with RLAI
- Patients requiring treatment at entry with mood stabilizers or antidepressants may enter the study only if a stable dose has been received for 3 months prior to study entry
- Previously received treatment with clozapine
- Known non-responders to previous treatment with at least 2 antipsychotics
- Mental retardation
- Patients with conditions and symptoms that are listed in the SmPC under special warnings and special precautions for use
- Acute risk of suicide in the investigator's opinion at study entry or history of suicidal attempt(s) in the last 3 months before the study entry
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT00369239
Start Date
March 1 2006
End Date
November 1 2007
Last Update
May 17 2011
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