An Efficacy and Safety Study of Long-Term Risperidone Microspheres in Participants With Schizophrenia

NCT ID: NCT00269919

Last Updated: 2014-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2008-08-31

Brief Summary

The purpose of this study is to evaluate the long-term efficacy and safety of a long-acting injectable formulation of risperidone (an antipsychotic medication) and its influence on quality of life, in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Detailed Description

This is an open-label (all people know the identity of the intervention) single-arm, and prospective study (study following participants forward in time) of risperidone microspheres in participants with schizophrenia. Participants will be treated with intramuscular (into a muscle) injections of either 25 milligram (mg) or 37.5 mg or 50 mg of risperidone twice weekly, every 2 weeks for 2 years. The total duration of study will be 2 years. The efficacy of participants will primarily be evaluated by total Positive and Negative Syndrome Scale (PANSS) score. Participants' quality of life and safety will be monitored throughout the study.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Risperidone Long-Acting Injectable (RLAI)

The RLAI 25 milligram (mg) or 37.5 mg or 50 mg will be administered intramuscularly (into a muscle) depending on Investigator's discretion every 2 weeks for 2 years.

Group Type: EXPERIMENTAL

Risperidone Long-Acting Injectable (RLAI)

Intervention Type: DRUG

The RLAI 25 mg or 37.5 mg or 50 mg will be administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.

Interventions

Risperidone Long-Acting Injectable (RLAI)

The RLAI 25 mg or 37.5 mg or 50 mg will be administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants diagnosed with schizophrenia or schizoaffective disorder (in-patients or out-patients)
• Participants currently having their symptoms well controlled with a stable dose of oral antipsychotic medication

Exclusion Criteria

• Participants who have never received any previous antipsychotic treatment
• Participants who have received clozapine during the last 3 months
• Participants with a serious unstable medical condition, including laboratory abnormalities
• Participants with a history of, or current symptoms of tardive dyskinesia (a complication of neuroleptic therapy involving involuntary movements of facial muscles) or neuroleptic malignant syndrome (a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness)
• Female participants who are pregnant or breast-feeding, or are of childbearing age without adequate contraception

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Korea, Ltd., Korea Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd., Korea

Locations

Seoul, , South Korea

Countries

South Korea

Other Identifiers

RIS-KOR-64

Identifier Type: -

Identifier Source: secondary_id

CR002089

Identifier Type: -

Identifier Source: org_study_id