Friday, February 2, 2007

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major depressive disorder: no evidence of behavior and suicidal ideation with antidepressant duloxetine

Researchers analyzed data from clinical trials of phase II and III on suicidal behavior and suicidal ideation in patients with major depressive disorder treated with duloxetine. The analysis revealed no significant difference in the incidence of suicide-related events with duloxetine compared with placebo in 12 trials (duloxetine: 1,812 patients, placebo: 1,814 patients). The difference in incidence with the method of Mantel-Haenszel (MHID) for suicidal behavior was found to be -0.03%, and -0002 the difference in the percentage of exposure time-adjusted (MHRD). Changes in suicidality item-3 scores to scale HAMD (Hamilton Depression Scale) showed greater improvement with duloxetine (MHID = -4.25%, p <>
N Acharya et al, J Clin Psychopharmacol 2006; 26: 587-594

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FDA: Paliperidone for the treatment of schizophrenia

The FDA (Food and Drug Administration) has approved Invega (paliperidone) release formulation prolungato.Il paliperidone is a new atypical antipsychotic for treatment of schizophrenia, the active metabolite of risperidone. Effectiveness Invega in the acute treatment of schizophrenia was evaluated in 3 placebo-controlled trials lasting 6 weeks. Clinical trials involved 1600 patients from 23 countries. Invega has been shown to improve symptoms in a statistically significant compared to placebo at all doses tested (3 to 15mg/die). Invega is also superior to placebo at the scale PSP (Personal and Social Performance). The most common adverse reactions reported in clinical trials were: akathisia and extrapyramidal disorders (involuntary movements, tremors and muscle stiffness). The rate of treatment discontinuation due to adverse events for subjects treated with Invega was Low: 2% for 3mg, 6mg 6%, 4% for 9mg, 5% for 12mg, vs. 5% for placebo.
Source: Johnson & Johnson, 2006