An Efficacy and Safety Study of Long Acting Injectable Risperidone and Oral Risperidone in Participants With Schizophrenia or Schizoaffective Disorder

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of long acting injectable (LAI) risperidone and oral risperidone treatment on participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) or schizoaffective disorder (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Korea, Ltd., Korea
• Treatments: Risperidone

Criteria

Inclusion Criteria: - Participants who will understand the objectives and necessary procedures of the study and have signed the informed consent form which specified that they were willing to participate in the study - Participants with schizophrenia or schizoaffective disorder requiring long-term antipsychotic drug therapy - Participants with pre-morbid global assessment of functioning score of 71 or higher at Screening - Participants who do not present clinically significant abnormality in biochemistry and electrocardiography - Participants who will be compliant with the study requirements (that is, filling in the questionnaire by themselves) and who are capable of actually performing and willing to implementing them

Exclusion Criteria: - Participants who had taken clozapine for the past three months - Participants with mental retardation (Intelligence Quotient less than 70 at the screening)

• Participants with history of or currently with a serious disease (cardiovascular, respiratory, neurological [including seizures or significant cerebrovascular], renal, hepatic, hematologic, endocrine, immunologic or other systemic disease) including clinically relevant abnormal level - Participants who have an allergic or hypersensitive reaction to risperidone or who are unresponsive to risperidone - Pregnant or lactating female participants