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]
INVEGA® SUSTENNA® contains paliperidone palmitate. The active ingredient, paliperidone palmitate, is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives.
INVEGA® SUSTENNA® (paliperidone palmitate) is indicated for the acute and maintenance treatment of schizophrenia in adults [see Clinical Studies].
Media Articles Related to Invega Sustenna (Paliperidone)
European Commission approves TREVICTA (paliperidone palmitate 3-monthly injection), for schizophrenia
Source: Schizophrenia News From Medical News Today [2016.06.02]
Janssen has announced that the European Commission (EC) has approved the use of TREVICTA® (paliperidone palmitate, a 3-'monthly injection) for the maintenance treatment of schizophrenia.
Novel Biomarkers of Early Schizophrenia Identified
Source: Medscape Psychiatry & Mental Health Headlines [2016.06.24]
MRI techniques reveal changes in the brains of rats that may denote early signs of schizophrenia, a discovery that could pave the way for early diagnosis and treatment of the disease in humans.
Medscape Medical News
Analysis of genetic repeats suggests role for DNA instability in schizophrenia
Source: Genetics News From Medical News Today [2016.06.24]
Variations in the number of DNA sequence repeats are known to exist between individuals.
Smoking while pregnant linked to schizophrenia in offspring
Source: Schizophrenia News From Medical News Today [2016.05.24]
Smoking during pregnancy may affect the mental health of offspring, increasing their risk of schizophrenia by 38 percent, new research suggests.
Schizophrenia, bipolar tied to yeast infection
Source: Bipolar News From Medical News Today [2016.05.05]
Research finds a history of Candida yeast infection is more common in men with schizophrenia or bipolar disorder and in women with these illnesses who have memory problems.
Published Studies Related to Invega Sustenna (Paliperidone)
Estimated medical cost reductions for paliperidone palmitate vs placebo in a
randomized, double-blind relapse-prevention trial of patients with
schizoaffective disorder. 
CONCLUSIONS: Use of PP1M for treatment of patients with schizoaffective disorder
Paliperidone palmitate once-monthly reduces risk of relapse of psychotic,
depressive, and manic symptoms and maintains functioning in a double-blind,
randomized study of schizoaffective disorder. 
CONCLUSIONS: Paliperidone monthly as monotherapy or adjunctive therapy
Relapse prevention study of paliperidone extended-release tablets in Chinese
patients with schizophrenia. 
patients with schizophrenia... CONCLUSIONS: This study confirms the findings from earlier pali ER global
Paliperidone palmitate versus risperidone long-acting injection in
markedly-to-severely ill schizophrenia subjects: onset of efficacy with
recommended initiation regimens. 
antipsychotics in markedly-to-severely ill schizophrenia subjects... CONCLUSIONS: Using the recommended dosing regimens for PP and RLAI, both PP and
Double-blind, placebo-controlled, pilot trial of paliperidone augmentation in
serotonin reuptake inhibitor-resistant obsessive-compulsive disorder. 
CONCLUSIONS: These results suggest that paliperidone augmentation is well
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.
The Paliperidone ER Observational Study of Economic, Functional, and Clinical Outcomes in Patients With Schizophrenia [Terminated]
The purpose of this study is to examine the long-term economic, functional and clinical
outcomes in schizophrenia patients who require a change in antipsychotic treatment, and are
changed to either paliperidone extended release (ER) or another oral atypical antipsychotic
agent (AAP) including aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone.
Paliperidone ER(Invega®) on Depressive Symptoms of Schizophrenia Patients [Recruiting]
A Comparative Study to Evaluate the Evolution of Medication Satisfaction and Adherence in Patients Unsatisfied With Current Oral Atypical Antipsychotics by Switching Medication to Paliperidone Palmitate [Completed]
The purpose of this study is to evaluate the change of medication satisfaction measured by
Medication Satisfaction Questionnaire (MSQ) from baseline to endpoint for patients who are
switched into paliperidone palmitate, either immediately or in a delayed mode.
A Pharmacokinetic and Safety Study of Paliperidone Palmitate (JNS010) in Participants With Schizophrenia [Completed]
The purpose of this study is to assess the pharmacokinetics (the study of the way a drug
enters and leaves the blood and tissues over time) and safety of paliperidone palmitate in
participants with schizophrenia (psychiatric disorder with symptoms of emotional
instability, detachment from reality, often with delusions and hallucinations, and
withdrawal into the self).
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 >>
Page last updated: 2016-06-24