Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks) in these subjects revealed a risk of death in the drug-treated subjects of between 1.6 to 1.7 times that seen in placebo-treated subjects. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated subjects was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. INVEGA™ (paliperidone) Extended-Release Tablets is not approved for the treatment of patients with dementia-related psychosis.
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INVEGA SUMMARY
INVEGA™
(paliperidone)
Extended-Release Tablets
Paliperidone, the active ingredient in INVEGA™ Extended-Release Tablets, is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. INVEGA™ contains a racemic mixture of (+)- and (-)- paliperidone.
INVEGA™ (paliperidone) Extended-Release Tablets is indicated for the acute and maintenance treatment of schizophrenia.
The efficacy of INVEGA™ in the acute treatment of schizophrenia was established in three 6-week, placebo-controlled, fixed-dose trials in subjects with schizophrenia.
The longer-term benefit of maintaining schizophrenic patients on monotherapy with INVEGATM after achieving a responder status for 6 weeks was demonstrated in a controlled trial (see CLINICAL PHARMACOLOGY: Clinical Trials). The physician who elects to use paliperidone for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
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NEWS HIGHLIGHTSMedia Articles Related to Invega (Paliperidone)
Metabolic Effects Significantly Lower With INVEGA(R) Compared To Olanzapine
Source: Health News from Medical News Today [2009.11.19]
New data from a 6-month open label randomised controlled trial show INVEGA® (paliperidone ER) is associated with significantly less metabolic effects compared to oral olanzapine in people with schizophrenia, while demonstrating comparable efficacy.1 The results were presented at the 15th Biennial Winter Workshop in Psychoses in Barcelona, Spain.
Immune System Activated In Schizophrenia
Source: Immune System / Vaccines News From Medical News Today [2009.11.19]
Researchers at the Swedish medical university Karolinska Institutet have discovered that patients with recent-onset schizophrenia have higher levels of inflammatory substances in their brains. Their findings offer hope of being able to treat schizophrenia with drugs that affect the immune system. The causes of schizophrenia are largely unknown, and this hinders the development of effective treatments.
Major Schizophrenia Study Finds Striking Similarities Across 37 Countries In Six Regions
Source: Mental Health News From Medical News Today [2009.11.16]
An international study of more than 17,000 people with schizophrenia has found striking similarities in symptoms, medication, employment and sexual problems, despite the fact that it covered a diverse range of patients and healthcare systems in 37 different countries.
World's Leading Experts In Schizophrenia To Meet At 26th Annual Pittsburgh Schizophrenia Conference Nov. 13
Source: Schizophrenia News From Medical News Today [2009.11.08]
Internationally renowned experts in schizophrenia and other psychotic disorders, researchers and clinicians, patients and their families and friends will gather in Pittsburgh to discuss the latest in research and clinical advances at the 26th Annual Pittsburgh Schizophrenia Conference to be held Friday, Nov. 13, at the Sheraton Station Square, Pittsburgh.
Schizophrenia
Source: MedicineNet Alcohol Abuse and Alcoholism Specialty [2009.10.30]
Title: Schizophrenia
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 10/30/2009
Published Studies Related to Invega (Paliperidone)
Paliperidone extended-release for schizophrenia: effects on symptoms and functioning in acutely ill patients with negative symptoms. [2009.08]
BACKGROUND: Most patients with schizophrenia exhibit negative symptoms, even during acute episodes. These difficult-to-treat symptoms are often associated with poor functioning and outcomes... CONCLUSIONS: Schizophrenia patients with predominant negative symptoms were identified in a population of acutely ill patients. Findings of this post-hoc analysis suggest that acutely ill patients with or without predominant negative symptoms respond similarly to treatment with paliperidone ER. No unexpected tolerability findings were observed.
The effects of paroxetine on the pharmacokinetics of paliperidone extended-release tablets. [2009.07]
INTRODUCTION: Co-morbid medical and psychiatric conditions are common in individuals with schizophrenia. As such, selecting antipsychotic medications with a low potential for drug-drug interactions (DDIs) is crucial, as many are extensively metabolized by hepatic cytochrome P450 (CYP) isozymes... DISCUSSION: Results suggest that no clinically relevant pharmacokinetic interaction occurs when paroxetine and paliperidone ER are co-administered and, therefore, initiation or discontinuation of concomitant treatment with CYP2D6-inhibiting drugs does not appear to warrant an adjustment in paliperidone ER dosage.
Randomized, double-blind, placebo-controlled study of paliperidone extended-release and quetiapine in inpatients with recently exacerbated schizophrenia. [2009.06]
CONCLUSIONS: Compared with quetiapine, paliperidone extended-release improved symptoms earlier and to a greater degree in patients with recently exacerbated schizophrenia requiring hospitalization, with no unexpected tolerability findings.
Paliperidone extended-release tablets in schizophrenia patients previously treated with risperidone. [2008.07]
To assess the effect of paliperidone extended-release (ER) tablets in patients with acute symptoms who had previously received risperidone. Data for this post-hoc analysis were pooled from three 6-week, double-blind, placebo-controlled trials in patients treated with paliperidone ER 3-12 mg/day or placebo...
Safety and tolerability of oral paliperidone extended-release tablets in elderly patients with schizophrenia: a double-blind, placebo-controlled study with six-month open-label extension. [2008.01]
Objective: The objective of this multicenter, international study was to evaluate safety and tolerability of paliperidone extended-release (ER) tablets in elderly (age >/=65 years) patients with schizophrenia. The authors conducted a 6-week, double-blind, randomized, placebo-controlled, optional 24-week open-label extension study.
Clinical Trials Related to Invega (Paliperidone)
A Study to Evaluate the Efficacy and Safety of Three Fixed Doses of Extended-Release Paliperidone in Subjects With Bipolar I Disorder [Recruiting]
The purpose of this study is to evaluate the effectiveness and safety of 3 different doses of paliperidone extended release (ER) compared to placebo in patients diagnosed with Bipolar I Disorder who are experiencing an acute manic or mixed episode. This study will also evaluate the effects of paliperidone extended release on global functioning, and the relationship between blood levels and the effectiveness and safety of paliperidone.
A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-Release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder [Active, not recruiting]
The purpose of this study is to evaluate the effectiveness and safety of flexible-doses paliperidone ER (3 to 12 mg as needed) compared with placebo over 3 weeks in patients with Bipolar I Disorder who are experiencing an acute manic or mixed episode. This study will also evaluate the effects of paliperidone ER on global functioning, and will compare the effectiveness of flexible doses of paliperidone ER to that of quetiapine over 12 weeks.
A Study to Evaluate the Efficacy and Safety of Adjustable Doses of Extended-Release (ER) Paliperidone Compared With Placebo, in Combination With Lithium or Valproate, to Treat Manic and Mixed Episodes in Patients With Bipolar I Disorder [Active, not recruiting]
The purpose of this study is to evaluate the effectiveness and safety over a 6-week period of paliperidone ER compared with placebo in treating subjects with Bipolar I Disorder who are experiencing a manic or mixed episode while they are taking lithium or valproate. This study will also evaluate the effect of paliperidone ER compared with placebo on overall functioning, on how quickly a response is seen, on improvement in severity of illness, on health-related functional status, on depressive symptoms, and on psychotic symptoms. The relationship between blood levels and the effectiveness and safety of paliperidone ER will be evaluated, including the effect of food relative to time of taking the drug.
Invega for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar Disorder [Recruiting]
This will be an 8-week open-label trial, using daily doses of paliperidone (Invega) in the
treatment of children and adolescents who meet DSM-IV criteria of Bipolar I, Bipolar II, or
Bipolar Spectrum Disorder. Specific hypotheses are as follows:
Hypothesis 1: Bipolar Disorder symptomatology in children and adolescents with DSM-IV
Bipolar I, Bipolar II, or Bipolar Spectrum Disorder will be responsive to Invega treatment.
Hypothesis 2: Invega - associated improvement in bipolar disorder symptomatology in children
and adolescents will translate into improved functional capacities (neuropsychological,
social, and occupational), as well as an increased quality of life throughout treatment.
Hypothesis 2: Invega treatment will be safe and well tolerated as reflected by a low drop
out rate and absence of major side effects.
Evaluation of Effectiveness and Safety of Paliperidone ER (Extended-Release) Compared With Quetiapine in Patients With Schizophrenia [Completed]
The purpose of this study is to evaluate the efficacy (effectiveness of drug) and safety of
the antipsychotic paliperidone ER compared to another antipsychotic, quetiapine, and to
placebo in patients who are acutely ill with symptoms of schizophrenia.
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Page last updated: 2009-11-19
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