Table 1.
Description of Trials Included in Current Analysis
| Int-212 (n = 1358) | Int-314 (n = 513) | Int-3513 (n = 553) | USA-12115 (n = 458) | Int-5717 (n = 582) | |
| Duration | 8 weeks | 8 weeks | At least 2 years. In current analysis, data up to 1 year included. | 12 weeks | 1 year |
| Population | Chronic inpatients, International | Chronic inpatients, USA | First episode, International | Acute, USA | Symptomatically stable, International |
| Design | RCT, double blind, 6 parallel groups (5 fixed doses risperidone and 1 haloperidol) | RCT, double blind, 6 parallel groups (4 fixed doses risperidone, 1 haloperidol and placebo) | RCT, double blind, 2 parallel groups (risperidone and haloperidol) | RCT, double blind, 2 parallel groups (injections of long-acting risperidone and placebo) | Open label single arm long-acting risperidone injectable |
| Female | 34.3% | 16.6% | 28.6% | 22.6% | 31.3% |
| Age, females | 40.5 SD 12.0 | 42.8 SD 11.0 | 26.6 SD 7.6 | 41.0 SD 8.9 | 46.6 SD 14.8 |
| Age, males | 36.8 SD 10.9 | 36.2 SD 9.8 | 24.9 SD 6.5 | 36.7 SD 9.5 | 39.6 SD 13.1 |
| Diagnosis, schizophrenia | All | All | 65.4%a | All | All |
| PANSS, baselineb | 89.7 SD 17.8 | 92.6 SD 18.9 | 82.4 SD 20.2 | 82.0 SD 13.8 | 67.1 SD 18.9 |
| PANSS, mean change to end point | −16.3 SD 22.7 | −8.0 SD 24.3 | −20.8 SD 23.5 | −4.2 SD 18.0 | −6.6 SD 16.6 |
Note: PANSS, Positive and Negative Syndrome Scale; RCT, randomized controlled trial.
a
6.7% schizoaffective, 27.9% schizophreniform.
b
Baseline and change results are for all treatment groups in the studies.