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Table 1 Randomized placebo-controlled studies available for analysis

From: Paliperidone ER and oral risperidone in patients with schizophrenia: a comparative database analysis

Paliperidone ER

Study

(Year Completed)

N*

Population

Dose (mg/day)

Duration (Weeks)

Efficacy Measures

Safety Measures

PALI-SCH-303 (2005) [7]

500

• Patients with schizophrenia, diagnosis for ≥1 yr

• Agreed to hospitalization for at least the first 14 days of the study

• Acute episode with PANSS total score 70-120

6, 9, 12 (qd)

6

PANSS, CGI

SAS, BARS, AIMS, AEs, labs, weight

PALI-SCH-304 (2004) [8]

327

• Patients with schizophrenia, diagnosis for ≥1 yr

• Agreed to hospitalization for at least the first 14 days of the study

• Acute episode with PANSS total score 70-120

6, 12 (qd)

6

PANSS, CGI

SAS, BARS, AIMS, AEs, labs, weight

PALI-SCH-305 (2005)

[9]

366

• Patients with schizophrenia, diagnosis for ≥1 yr

• Agreed to hospitalization for at least the first 14 days of the study

• Acute episode with PANSS total score 70-120

3, 9, 15 (qd)

6

PANSS, CGI

SAS, BARS, AIMS, AEs, labs, weight

Risperidone

Study

N

Population

Dose (mg/day)

Duration (Weeks)

Efficacy Measures

Safety Measures

RIS-USA-1 (1990)

160

• Patients with schizophrenia

• Inpatients at the start of the study

• Minimum BPRS score of 30, with a minimum score of at least moderate (4) on 2 of the following items: conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content

1-10§ (qd)

6

BPRS, CGI

ESRS, AIMS, AEs, labs, weight

RIS-INT-3 (1991) [5]; [6]

523

• Patients with chronic schizophrenia

• Inpatients at the start of the study

• PANSS total score 60-120

2, 6, 10,16 (bid)

8

PANSS, CGI

ESRS, AEs, labs, weight

RIS-USA-72 (1996)

246

• Patients with schizophrenia

• Inpatients at the start of the study

• PANSS total score 80-120, with a PANSS score ≥8 for the sum of 2 of the following items: conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content

4, 8 (qd)

4

PANSS

ESRS, AEs, labs, weight

  1. *Intent-to-treat population.
  2. N values represent subjects who received the recommend dose of paliperidone ER (3-12 mg/day) or placebo.
  3. Data on file.
  4. §Flexible dosing.
  5. PANSS = Positive and Negative Syndrome Scale; CGI = Clinical Global Impressions; SAS = Simpson-Angus Scale; BARS = Barnes Akathisia Rating Scale; AIMS = Abnormal Involuntary Movement Scale; AEs = adverse events; BPRS = Brief Psychiatric Rating Scale; ESRS = Extrapyramidal Symptoms Rating Scale.