Conditions: Schizophrenia Schizoaffective Disorder
Keywords: Schizophrenia Risperidone Risperidal Consta
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 40
Healthy volunteers: no

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.

Arms:
arm 1: 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.

Interventions: intervention 1: Risperidone Long-Acting Injectable (RLAI)
Intervention descriptions: intervention 1: 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.

Protocol document: