Conditions: Schizophrenia
Keywords: Schizophrenia Risperidone Risperdal Paliperidone Palmitate Invega Sustenna
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 163
Healthy volunteers: no

Brief summary:
The study will assess the use of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse.

Detailed description:
This is a Prospective, Randomized, Active-controlled, Rater-blinded Study to to assess the efficacy of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse. Recently diagnosed is defined as first diagnosis of any psychotic disorder within 5 years prior to screening. High risk of relapse is defined as having documented occurrence of 3 periods of breakthrough symptoms that required a change in patient care per the investigator's judgment (e.g., increase in dose, addition of a new drug, increase in the level of psychiatric care, notable increases in the frequency or intensity of patient contact required to maintain outpatient status, psychiatric hospitalization, etc.) within the previous 24 months, including 1 such period within the previous 6 months. Safety evaluations will include Adverse Event (AE) reporting, hematology and clinical chemistry laboratory tests, vital signs, electrocardiogram (ECG), and evaluations of suicidality and sexual functioning. Patients will receive either paliperidone palmitate 50, 75, 100, or 150 mg eq. monthly by injection for two years or oral risperidone 2, 4, 6, or 8 mg tabs once daily for two years.

Arms:
arm 1: paliperidone palmitate 50 75 100 or 150 mg eq. monthly injection for 2 years arm 2: oral risperidone 2 4 6 or 8 mg tabs once daily for two years

Interventions: intervention 1: paliperidone palmitate intervention 2: oral risperidone
Intervention descriptions: intervention 1: 50, 75, 100, or 150 mg eq. monthly injection for 2 years intervention 2: 2, 4, 6, or 8 mg tabs once daily for two years

Protocol document: