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Results From Paliperidone Study Demonstrate Improved Symptoms of Schizoaffective Disorder
"This well-designed and conducted study of paliperidone ER in patients with schizoaffective disorder found that this medication is both efficacious and well-tolerated," said Nina Schooler, Ph.D., SUNY Downstate Medical Center. "These new data support the potential use of paliperidone ER as an effective option for the treatment of this understudied group of patients."
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. 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 but within those people that frequently use mental health services, schizophrenia and schizoaffective disorder may account for approximately 32% and 24% of cases respectively.
In the six week, international, randomized, double-blind, placebo controlled study, 311 patients with an established diagnosis of schizoaffective disorder, who were experiencing acute symptoms, were randomized to receive either paliperidone ER or a placebo. The paliperidone ER dose was initiated at 6 mg/day and could be adjusted in range from 3mg/day to 12mg/day up to day 15, after which no dose adjustments were allowed. In addition to study medication, subjects were permitted to receive concomitant treatment with an antidepressant and/or mood stabilizer, provided these medications had been given at a stable dose within 30 days of screening. Approximately half the subjects enrolled received ongoing treatment with an antidepressant and/or mood stabilizer during the study.
Based on the primary outcome parameter of change in PANSS total score from baseline to week 6 endpoint results showed that patients in the paliperidone ER group had significantly greater improvement as compared to patients on placebo (p=0.001). Changes were also noted in many secondary outcomes parameters measured in the trial. The paliperidone ER group exhibited a significant improvement in mean Clinical Global Impressions of Severity for Schizoaffective Disorder (CGI-S-SCA) scores when compared to patients taking placebo (p=0.002). Further, among patients with prominent manic symptoms as measured by the Young Mania Ratings Scale (YMRS score greater than or equal to 16) paliperidone ER exhibited significant improvement compared to placebo on the YMRS (p=0.001). Likewise, among patients with prominent depressive symptoms as measured by the Hamilton Rating Scale for Depression (HAM-D-21 score greater than or equal to 16), paliperidone ER exhibited significant improvements compared to placebo on the HAM-D-21 (p The most common adverse events occurring in this trial were: headache (32%), dizziness (18%), insomnia (14%), akathisia (13%) and dyspepsia (12%).
The study was sponsored by Ortho-McNeil Janssen Scientific Affairs, LLC.
Source: Ortho-McNeil Janssen Scientific Affairs