Status:
COMPLETED
An Efficacy and Safety Study of Risperidone Long-Acting Microspheres in Participants With Schizophrenia, Schizophreniform or Schizoaffective Disorders
Lead Sponsor:
Janssen-Cilag Ltd.
Conditions:
Schizophrenia
Schizophreniform Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of long acting injectable microspheres of risperidone in participants with schizophrenia (psychiatric disorder with symptoms of emotion...
Detailed Description
This is an open-label (all people know the identity of the intervention), longitudinal (participants are followed over time with continuous or repeated monitoring of risk factors or health-outcomes), ...
Eligibility Criteria
Inclusion
- Symptomatically stable participants defined as a) participants with treatment on outpatient and inpatient basis for at least 4 weeks before entering the study, and b) Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score less than or equal to (\<= ) 3 (1-7), including conceptual disorganization, suspicion, hallucinatory conduct and delirium (state of violent mental agitation)
- Participants under antipsychotic treatment with extrapyramidal symptoms, persistent negative symptoms or lack of adherence defined as irregular administration of medication in the last 2 weeks
- Participants who have given their informed consent in writing, or at least, by their family member or personal representative
Exclusion
- Participants taking first antipsychotic treatment in his/her life
- Participants with any other psychotic disorder different to the previously mentioned in the inclusion criteria
- Pregnant or nursing women
- History of neuroleptic malignant syndrome (potentially fatal syndrome associated primarily with the use of antipsychotic drugs and clinical features include diffuse muscle rigidity, tremor, high fever) or current symptoms of tardive dyskinesia (a neurological disorder characterized by involuntary movements of the face and jaw)
- Participants with known intolerance or lack of response to risperidone
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01855074
Start Date
November 1 2007
End Date
February 1 2009
Last Update
August 14 2013
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