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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 4

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: Risperidone Long-Acting Injectable (RLAI)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00269919

RIS-KOR-64

CR002089

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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
• Participants who have signed informed consent form 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Risperidone Long-Acting Injectable (RLAI)

Experimental group

Description:

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.

Treatment:

Drug: Risperidone Long-Acting Injectable (RLAI)