WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients 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. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. INVEGA® SUSTENNA® (paliperidone palmitate) is not approved for the treatment of patients with dementia-related psychosis. [See Warnings and Precautions]
Media Articles Related to Invega Sustenna (Paliperidone)
Brain region essential for social memory offers a potential target for autism, schizophrenia, other brain disorders
Source: Autism News From Medical News Today [2014.02.25]
Columbia University Medical Center (CUMC) researchers have determined that a small region of the hippocampus known as CA2 is essential for social memory, the ability of an animal to recognize another of the same species.
Schizophrenia linked to increased risk of autoimmune diseases
Source: Infectious Diseases / Bacteria / Viruses News From Medical News Today [2014.02.25]
People suffering from schizophrenia are at greater risk of developing autoimmune diseases such as psoriasis and multiple sclerosis. This is the conclusion of new research from Aarhus University. It appears that infections play a determining role.
Gathering the clues to rare gene variants contributing to schizophrenia
Source: Schizophrenia News From Medical News Today [2014.02.21]
Schizophrenia has long been known to be highly heritable and is present in approximately 1% of the population. Researchers have been following two paths in their pursuit of identifying schizophrenia risk genes.
Potential new circuit to target to improve understanding of schizophrenia and bipolar disorder
Source: Bipolar News From Medical News Today [2014.02.20]
To answer the seemingly simple question "Have I been here before?" we must use our memories of previous experiences to determine if our current location is familiar or novel.
The connection between memory and schizophrenia
Source: Schizophrenia News From Medical News Today [2014.02.18]
Many psychiatric disorders are accompanied by memory deficits. Basel scientists have now identified a network of genes that controls fundamental properties of neurons and is important for human brain activity, memory and the development of schizophrenia. Their results have been published in the online edition of the US journal Neuron.The ability to hold transitory information - e.g.
Published Studies Related to Invega Sustenna (Paliperidone)
Bilastine: in allergic rhinitis and urticaria. 
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. 
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.
Clinical Trials Related to Invega Sustenna (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 (INVEGAÂ® SUSTENNAâ„˘) 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 (INVEGAÂ® SUSTENNAâ„˘) 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.
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
Reports of Suspected Invega Sustenna (Paliperidone) Side Effects
Drug Dose Omission (179),
Device Leakage (78),
Drug Ineffective (77),
Weight Increased (72),
Product Quality Issue (61),
Condition Aggravated (53),
Psychotic Disorder (48),
Inappropriate Schedule of Drug Administration (47),
Injection Site Pain (47),
Hospitalisation (44), more >>