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Invega (Paliperidone) - Summary

 
 



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.

 

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.


See all Invega indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Invega (Paliperidone)

Rapid Rise in Cardiometabolic Risk in Early Schizophrenia
Source: Medscape Psychiatry & Mental Health Headlines [2014.10.14]
Patients with first-episode schizophrenia frequently experience a rapid rise in cardiometabolic risk factors.
Medscape Medical News

Schizophrenia Pictures Slideshow: Types, Causes, Symptoms, and Treatment
Source: MedicineNet Alcohol Abuse and Alcoholism Specialty [2014.10.14]
Title: Schizophrenia Pictures Slideshow: Types, Causes, Symptoms, and Treatment
Category: Slideshows
Created: 9/27/2010 9:31:00 AM
Last Editorial Review: 10/14/2014 12:00:00 AM

Family carers of people with schizophrenia are a hidden workforce at breaking point
Source: Caregivers / Homecare News From Medical News Today [2014.10.13]
Approximately three out of four (72%) carers of those living with schizophrenia, are mainly (34%) or solely (38%) responsible for caring, placing a huge emotional and physical burden on them...

Schizophrenia: shattering the stigma
Source: Mental Health News From Medical News Today [2014.10.10]
For this year's World Mental Health Day, the theme is 'Living with Schizophrenia.' In line with this campaign, we investigate the stigma attached to the disorder.

Cardio Risk High With New-Onset Schizophrenia
Source: MedPage Today Psychiatry [2014.10.09]
(MedPage Today) -- Drug side effects not the most important factor.

more news >>

Published Studies Related to Invega (Paliperidone)

Bilastine: in allergic rhinitis and urticaria. [2012]
Bilastine is an orally administered, second-generation antihistamine used in the symptomatic treatment of seasonal or perennial allergic rhinoconjunctivitis and urticaria. In two well designed phase III trials, 14 days' treatment with bilastine was associated with a significantly lower area under the effect curve (AUEC) for the reflective total symptom score (TSS) than placebo in patients with symptomatic seasonal allergic rhinitis...

A randomized, placebo- and active-controlled study of paliperidone extended-release as maintenance treatment in patients with bipolar I disorder after an acute manic or mixed episode. [2012]
patients with this disorder... CONCLUSIONS: Paliperidone ER significantly delayed the time to recurrence of any

Oral paliperidone: a review of its use in the management of schizoaffective disorder. [2011.06.01]
Oral paliperidone extended or prolonged release (Invega(R)) is an atypical antipsychotic, and is the first agent approved for the treatment of schizoaffective disorder. Paliperidone (or 9-hydroxyrisperidone) is the major active metabolite of the well known atypical antipsychotic risperidone, and its mechanism of action is thought to be the antagonism of dopamine D(2) and serotonin 5-HT(2A) receptors...

Paliperidone extended-release as adjunctive therapy to lithium or valproate in the treatment of acute mania: a randomized, placebo-controlled study. [2011.03]
BACKGROUND: Combination treatment with atypical antipsychotics and a mood stabilizer is often recommended for treatment of manic or mixed episodes associated with bipolar I disorder... CONCLUSIONS: In this study, flexibly-dosed paliperidone ER used as adjunctive therapy to mood stabilizers did not demonstrate efficacy over mood stabilizer monotherapy. No new safety signals were observed with combination treatment in this population. Copyright (c) 2010 Elsevier B.V. All rights reserved.

Evaluation of the effect of paliperidone extended release and quetiapine on corrected QT intervals: a randomized, double-blind, placebo-controlled study. [2011.01]
The effect of two atypical antipsychotics on QTc intervals (heart rate-corrected QT interval) was evaluated. Patients (N=109) with schizophrenia (79%) or schizoaffective disorder (21%) were randomly assigned in 2 : 2 : 1 ratio to paliperidone extended release (ER), quetiapine, or placebo... The effect on the QTc interval in patients with schizophrenia or schizoaffective disorder was comparable between paliperidone ER 12 mg/day (maximum recommended dose), paliperidone ER 18 mg/day (supratherapeutic dose), and quetiapine 800 mg/day.

more studies >>

Clinical Trials Related to Invega (Paliperidone)

Contrasting the Brain Effects of Risperidone and Invega With Functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) Scanning [Recruiting]
The purpose of this study is to better understand brain function and psychiatric and neurological illness when taking Invega or Risperdal. The objective is to compare the brain effects of Invega to Risperdal in patients with Schizophrenia. This comparison will be evaluated with PET imaging, fMRI, and neurological ratings and assessments.

Paliperidone Palmitate Efficacy and Safety in Bipolar Disorder Complicated by Alcoholism [Not yet recruiting]
Our primary specific aim is to examine the efficacy of Paliperidone extended release Paliperidone Palmitate Injection (INVEGA® SUSTENNA™) compared to placebo in decreasing manic symptoms in patients with comorbid DSM-IV bipolar disorder and alcohol dependence. We hypothesize that the Paliperidone Palmitate Injection (INVEGA® SUSTENNA™) treated group will have a statistically significant advantage on improvement in manic symptoms. They will also have higher rate of treatment response and remission.

A Study to Evaluate the Response to Treatment and Safety of Flexible Dose Treatment With Extended-release Paliperidone in Patients With Schizophrenia [Recruiting]
This study will explore the efficacy and safety of flexibly dosed paliperidone ER in subjects with schizophrenia.

Hypothesis:

At the end of 12 months, flexible dose paliperidone treatment is expected to improve functionality and satisfaction of schizophrenia patients significantly as measured by PSP. The expected increase in PSP score is approximately 10-20%

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.

Paliperidone Extended-Release (ER) Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia [Recruiting]
Primary objective: To examine whether the switch to paliperidone ER from risperidone improves cognitive function in stabilized patients with schizophrenia.

Secondary objectives: To compare the general clinical outcomes (efficacy and safety) after switching to paliperidone ER from risperidone

more trials >>

Reports of Suspected Invega (Paliperidone) Side Effects

Extrapyramidal Disorder (31)Drug Ineffective (30)Depression (28)Weight Increased (27)Dystonia (24)Insomnia (23)Pain (22)Somnolence (22)Abnormal Behaviour (22)Tardive Dyskinesia (22)more >>


Page last updated: 2014-10-14

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