Treatment With Paliperidone ER Improves Symptoms Of Schizoaffective Disorder
Patients with schizoaffective disorder receiving paliperidone extended release tablets (paliperidone ER) for six weeks showed a significant improvement in their symptoms, according to a new study presented today at the U.S. Psychiatric & Mental Health Congress in San Diego, Calif.(1) In addition, safety findings were similar to published studies of paliperidone ER in the treatment of schizophrenia.(2)(3)
"Schizoaffective disorder is an under studied condition that despite being common among patients with serious mental illness, has no approved treatment," said Husseini Manji, M.D., Vice President, Central Nervous System and Pain, Johnson & Johnson Pharmaceutical Research and Development. "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."
Schizoaffective disorder is a condition, which encompasses the symptoms of both schizophrenia and a major mood disorder. Patients with schizoaffective disorder experience the psychosis characteristic of schizophrenia, such as hallucinations or delusions, as well as symptoms of mania and/or depression.(4) Schizoaffective disorder can be difficult to distinguish from schizophrenia or bipolar disorder because the symptoms are similar to both. The disorder is about one third as common as schizophrenia(5) but within those people that frequently use mental health services, schizophrenia and schizoaffective disorder may account for approximately 32% and 24% of cases respectively.(6)
In the 6 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. No dose adjustments were permitted after day 15. In addition to study medication, patients were also permitted to receive previously prescribed anti-depressants and/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](a) paliperidone ER had significantly improved symptoms, based on the primary outcome parameter of total change in mean PANSS(b) scores, compared to patients on placebo (p=0.003). The lower dose group [5.7 mg/day](c), 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)(d) 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.