Innovations In Clinical Neuroscience

NOV-DEC 2017

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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44 ICNS INNOVATIONS IN CLINICAL NEUROSCIENCE November-December 2017 • Volume 14 • Number 11–12 O R I G I N A L R E S E A R C H TABLE 1: Demographic information of study population INTERNAL ID NCT TREATMENTS N TX N PLACEBO N MALE (%) PANSS (MEAN) PANSS (SD) AGE IN YEARS (MEAN) AGE IN YEARS (SD) INCLUSION R092670-SCH-201 NCT00074477 paliperidone palmitate 126 52 178 65.7% 81.10 13 38.98 10.47 Subjects diagnosed with schizophrenia according to DSM-IV (disorganized type [295.10], catatonic type [295.20], paranoid type [295.30], residual type [295.60], or undifferentiated type [295.90]) at least 1 year before screening; total PANSS score must be between 70 and 120, inclusive, at screening, and 60 and 120, inclusive, at Day 1 (before start of double-blind study drug) R076477-SCH-304 NCT00077714 paliperidone extended- release 242 73 315 73.0% 93.60 10.7 41.81 10.56 Diagnosis of schizophrenia according to DSM-IV criteria (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year before screening; experiencing an acute episode, with a PANSS total score at screening between 70 and 120 R076477-SCH-305 NCT00083668 paliperidone extended- release, olanzapine 516 0 516 66.5% 93.90 11.8 36.74 10.54 Experiencing an acute episode, with a total PANSS score at screening between 70 and 120 R076477-SCH-302 NCT00085748 paliperidone extended-release 63 30 93 25.8% 105.20 13.9 69.58 4.56 DSM-IV diagnosis of schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year before screening; total PANSS score at screening and baseline (Visit 2) between 70 and 120, inclusive R076477-SCH-301 NCT00086320 paliperidone extended-release 63 30 164 61.0% 92.10 11.3 39.78 9.8 DSM-IV diagnosis of schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90); Diagnosis of schizophrenia at least 1 year before screening; experiencing an acute schizophrenic episode with a total PANSS score between 70 and 120, inclusive, both at screening and at baseline (the start of the run-in phase) R092670-PSY-3004 NCT00101634 paliperidone palmitate 283 89 372 63.2% 87.00 11 40.01 11.28 Patients who meet diagnostic criteria for schizophrenia according to DSM-IV for at least 1 year who meet PANSS score criteria and have BMI of >15.0kg/m 2 ; PANSS total score at screening and baseline of 70 to 120, inclusive R092670-PSY-3003 NCT00210548 paliperidone palmitate 139 98 237 67.1% 91.00 11.9 39.07 10.36 Met diagnostic criteria for schizophrenia according to DSM IV (disorganized type [295.10], catatonic type [295.20], paranoid type [295.30], residual type [295.60] or undifferentiated type [295.90]) for at least 1 year before screening; a total PANSS score at screening and at baseline of between 70 and 120, inclusive R092670-PSY-3002 NCT00210717 paliperidone palmitate, risperidone 576 0 576 58.5% 90.80 12.1 40.7 11.69 Met diagnostic criteria for schizophrenia according to DSM-IV (disorganized type [295.10], catatonic type [295.20], paranoid type [295.30], residual type [295.60], or undiffe entiated type [295.90]) for at least 1 year before screening; a total PANSS score between 60 and 120, inclusive R076477-SCH-3015 NCT00334126 paliperidone extended- release, quetiapine 170 34 204 58.3% 92.80 12.4 35.92 10.76 Met DSM-IV diagnosis of schizophrenia (paranoid, disorganized or undifferentiated type); score of ≥4 on at least two of a subset of selected PANSS items and a total score on these five items of ≥17; score of ≥5 on the CGI-S R092670-PSY-3007 NCT00590577 paliperidone palmitate 333 104 437 65.9% 87.30 11.7 39.42 10.7 Met diagnostic criteria for schizophrenia according to DSM-IV (disorganized type [295.10], catatonic type [295.20], paranoid type [295.30], residual type [295.60] or undifferentiated type [295.90]) for at least 1 year before screening; prior medical records, written docu- mentation, or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia; a total PANSS score at screening of between 70 and 120, inclusive and at baseline of between 60 and 120, inclusive. R076477-SCH-303 NCT00650793 paliperidone extended- release, olanzapine 446 109 555 50.6% 92.90 9.2 37.15 10.86 Subjects must have been diagnosed with schizophrenia according to DSM-IV (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year prior to screening; subjects must be experiencing an acute episode, with a total PANSS score at screening between 70 and 120 NCT: clinicaltrials.gov number; TX: treatment; N: number; SD: standard deviation; DSM-IV: Diagnostic and Statistcal Manual of Mental Disorders, Fourth Edition; PANSS: Positive and Negative Syndrome Scale; BMI: body mass index; CGI-S: Clinical Global Impression-severity

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