Study population
schizophrenia, Hostility, schizoaffective disorder
Details on the eighteen randomized, placebo-controlled trials comprising 6685 participants (90% with schizophrenia and 10% with schizoaffective disorder, mean age: 38.1 ± 12.3 years, 33.6% female) are provided in Table All 18 trials were conducted in exacerbated patients with schizophrenia. Fifteen out of eighteen trials enforced an inclusion criterion of a PANSS-30 score between 60, 70 or 80 to 120, with 70 to 120 being the most common (nine out of eighteen trials). For two trials, a PANSS-30 score of more than 60 was required for inclusion, while for one trial there was no inclusion criterion directly related to the PANSS-30 score. That trial instead applied a CGI-S score of at least 5 as an inclusion criterion. Three trials (R076477-SCA-3001, R076477-SCA-3002 and R076477-SCH-3015) required a score of at least four points on at least two out of P4 Excitement, P7 Hostility, G4 Tension, G8 Uncooperativeness or G14 Poor Impulse Control, while one trial (RIS-USA-72) required a score of at least four points on at least two out of P2 Hallucinatory Behavior, P3 Conceptual Disorganization, G6 Suspiciousness/Persecution or G9 Unusual Thought Content. No trial required that positive symptoms were more prevalent/severe than negative symptoms, or vice versa. Eleven out of eighteen trials specified that the trial only included patients with either an acute exacerbation or acute episode of schizophrenia, while seven trials did not (PALM-JPN-4, R092670-PSY-3003, R092670-PSY-3004, R092670-SCH-201, RIS-INT-3, RIS-USA-72 and RIS-USA-121). These seven trials did, however, enforce the same PANSS-based inclusion criteria and the study report for R092670-PSY-3007, for example, specified that the trial included patients with an acute episode of schizophrenia, defining this as a PANSS-30 score of 70 to 120, whereas studies R092670-PSY-3003 and R092670-PSY-3004 utilized the same PANSS criteria but did not use the term acute episode. Across these 18 trials, 46 active antipsychotic arms were compared with 18 placebo arms. The 46 active antipsychotic trial arms included 18 paliperidone extended release (ER) arms, 12 paliperidone palmitate arms, 8 risperidone arms, 3 risperidone depot arms, 3 olanzapine arms, 1 quetiapine arm, and 1 haloperidol arm.