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news.Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals, has announced positive results from a new study which showed that patients with schizoaffective disorder receiving paliperidone extended release tablets for six weeks demonstrated a significant improvement in their symptoms. In addition, safety findings were similar to published studies of paliperidone ER in the treatment of schizophrenia.
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In the six week, international, randomized, double-blind, placebo controlled study, 316 patients with an established diagnosis of schizoaffective disorder, who were experiencing acute symptoms, received either 6mg/day or 12mg/day paliperidone ER, or a placebo. Dosages could be reduced to 3mg/day or 9mg/day respectively with the option to increase back to the originally assigned dose.
In addition to study medication, patients were also permitted to receive previously prescribed anti-depressants or mood stabilizers during the duration of the trial, if on a stable dosage within 30 days of screening.
The results showed that patients in the higher dose group (11.6 mg/day) paliperidone ER had significantly improved symptoms, based on the primary outcome parameter of total change in mean PANSS scores, compared to patients on placebo (p=0.003). The lower dose group (5.7 mg/day), however, did not show a statistically significant difference from placebo.
Significantly more patients in both the higher and lower dose groups achieved overall response (defined as at least 30% improvement on the PANSS and a Clinical Global Impressions of Change for Schizoaffective Disorder (CGI-C- SCA) of much or very much improved) when compared to patients taking placebo (p less than or equal to 0.008).
Further, among patients with prominent mood symptoms as measured by the Young Mania Ratings Scale and the Hamilton Rating Scale for Depression, compared to placebo the higher dose group demonstrated significantly greater improvement in symptoms on mania (p<0.001) and depression (p=0.032), while the low dose group showed greater improvement in symptoms of depression (p=0.013). The study itself was not designed to compare the relative effect of paliperidone ER as a monotherapy or in combination with anti-depressants and/or mood stabilizers, however, results showed the effect of paliperidone ER was evident in both patients treated with monotherapy and with combination therapy. Husseini Manji, vice president of central nervous system and pain at Johnson & Johnson Pharmaceutical R&D, said: "Schizoaffective disorder is an under studied condition that despite being common among patients with serious mental illness, has no approved treatment. This new study suggests that paliperidone ER could be an effective option for the treatment of schizoaffective disorder. Additional studies are needed to confirm this finding.