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| |  Paliperidone Effective and Well Tolerated in Patients With Bipolar I Disorder Experiencing Acute Manic or Mixed Episodes: Presented at ECNP By Judith Moser, MD BARCELONA, Spain -- September 3, 2008 -- Paliperidone extended release (ER) induces significant improvements in a variety of parameters such as patient functioning, severity of illness, and psychotic features among patients with bipolar I disorder experiencing acute manic or mixed episodes, according to 3-week data from a randomised, placebo- and active-controlled study. The multicentre study was presented here on September 1 at the 21st European College of Neuropsychopharmacology Congress (ECNP) by Joris Berwaerts, MD, Johnson & Johnson Pharmaceutical Research & Development, Titusville, New Jersey. In their study, Dr. Berwaerts and colleagues evaluated the antimanic efficacy and safety of flexibly-dosed paliperidone ER, a new antipsychotic agent, in 493 adult patients with bipolar I disorder experiencing acute manic or mixed episodes. Participants were randomised to receive paliperidone ER 3 to 12 mg QD (n = 190), quetiapine 400 to 800 mg QD (n = 192), or placebo (n = 104) for 3 weeks. The primary endpoint was change in the Young Mania Rating Scale (YMRS) score from baseline to 3 weeks. Paliperidone ER was shown to be superior to placebo in the primary endpoint, with a mean change in YMRS score of -13.2, compared with -11.7 for quetiapine and -7.4 for placebo (paliperidone vs placebo; P .001). Regarding the secondary endpoints, paliperidone proved superior to placebo with significant differences as measured by the Global Assessment of Functioning (GAF) score (P .001), the Clinical Global Impression-Bipolar Disorder-Severity of Illness (CGI-BP-S) scale score (P .001) and the Positive and Negative Syndrome Scale (PANSS) score (P = .002). Quality of sleep was also improved significantly in the paliperidone group compared with placebo (P .001). "As safety measures we included the Montgomery-Asberg Depression Rating Scale and the scale for suicidal ideation," Dr. Berwaerts explained. "For both of those safety parameters, the change from baseline to week 3 was superior for paliperidone ER compared to placebo." The percentage of patients who met the criteria for a switch to depression was twice as high in the placebo group, suggesting that paliperidone does not increase the risk of switching from mania to depression, according to the researchers. The overall number of adverse events did not show significant differences across the 3 treatment groups. Serious adverse events occurred at a similar rate (3%-5%), as well as events that led to discontinuation (4%-5%). The incidence of adverse events related to extrapyramidal symptoms or potentially to prolactin elevation was higher in the paliperidone group than in the placebo group. However, all events were considered mild or moderate. "These data clearly indicate that paliperidone ER was efficacious in the treatment of acute mania," Dr. Berwaerts concluded. Funding for this study was provided by Johnson & Johnson.
[Presentation title: Randomized, Placebo- and Active-Controlled Study of Paliperidone ER for Acute Manic and Mixed Episodes in Bipolar I Disorder. Abstract 2e018]
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