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 seventeen 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. Geodon (ziprasidone) is not approved for the treatment of patients with Dementia-Related Psychosis (see WARNINGS).
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GEODON SUMMARY
GEODON® (ziprasidone HCl) Capsules
GEODON® (ziprasidone mesylate) for Injection
GEODON® is available as GEODON Capsules (ziprasidone hydrochloride) for oral administration and as GEODON for Injection (ziprasidone mesylate) for intramuscular injection. Ziprasidone is an antipsychotic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents.
Ziprasidone is indicated for the treatment of schizophrenia. When deciding among the alternative treatments available for this condition, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs (see WARNINGS). Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known (see WARNINGS).
Ziprasidone intramuscular is indicated for the treatment of acute agitation in schizophrenic patients for whom treatment with ziprasidone is appropriate and who need intramuscular antipsychotic medication for rapid control of the agitation. "Psychomotor agitation" is defined in DSM-IV as "excessive motor activity associated with a feeling of inner tension." Schizophrenic patients experiencing agitation often manifest behaviors that interfere with their diagnosis and care, e.g., threatening behaviors, escalating or urgently distressing behavior, or self-exhausting behavior, leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the agitation. The efficacy of intramuscular ziprasidone for acute agitation in schizophrenia was established in single-day controlled trials of schizophrenic inpatients (see CLINICAL PHARMACOLOGY). Since there is no experience regarding the safety of administering ziprasidone intramuscular to schizophrenic patients already taking oral ziprasidone, the practice of co-administration is not recommended.
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NEWS HIGHLIGHTSMedia Articles Related to Geodon (Ziprasidone)
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
Forest Laboratories, Inc. And Gedeon Richter Announce Positive Results From A Phase IIb Study Of Cariprazine For The Treatment Of Schizophrenia
Source: Schizophrenia News From Medical News Today [2009.10.29]
Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc announced positive top-line results from a Phase IIb clinical trial of the novel, investigational antipsychotic agent cariprazine for the treatment of acute exacerbation of schizophrenia.
Published Studies Related to Geodon (Ziprasidone)
Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: the MOZART study. [2009.08]
This 18-week, randomized, flexible-dose, double-blind, double-dummy trial evaluated ziprasidone as an alternative to clozapine in treatment-refractory schizophrenia patients. Patients had a DSM-IV diagnosis of schizophrenia, a history of resistance and/or intolerance to at least three acute cycles with different antipsychotics given at therapeutic doses, PANSS score >or= 80, and CGI-S score >or= 4...
Ziprasidone Vs Olanzapine in Recent-Onset Schizophrenia and Schizoaffective Disorder: Results of an 8-Week Double-Blind Randomized Controlled Trial. [2009.06.19]
Introduction: Head-to-head comparisons of antipsychotics have predominantly included patients with chronic conditions. The aim of the present study was to compare the efficacy and tolerability of ziprasidone and olanzapine in patients with recent-onset schizophrenia... Clinically significant weight gain and laboratory abnormalities appear early after initiating treatment and are more prominent with olanzapine, while more patients on ziprasidone received anticholinergic drugs to treat extrapyramidal symptoms.
Long-term safety and efficacy of ziprasidone in subpopulations of patients with bipolar mania. [2009.06]
CONCLUSION: Sustained and comparable improvements in symptoms were seen with up to 55 weeks of ziprasidone treatment for patients initially treated for bipolar mania, regardless of whether the baseline episode was manic or mixed or involved psychotic symptoms. Copyright 2009 Physicians Postgraduate Press, Inc.
Effect of ziprasidone dose on all-cause discontinuation rates in acute schizophrenia and schizoaffective disorder: a post-hoc analysis of 4 fixed-dose randomized clinical trials. [2009.06]
CONCLUSIONS: Consistent with previous reports, higher doses of ziprasidone (120-160 mg/d, dosed twice daily with meals) are associated with significantly lower all-cause discontinuation rates and more favorable NNTs versus placebo. This was primarily driven by lower rates of discontinuation due to lack of efficacy.
Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: the MOZART study. [2009.05]
This 18-week, randomized, flexible-dose, double-blind, double-dummy trial evaluated ziprasidone as an alternative to clozapine in treatment-refractory schizophrenia patients. Patients had a DSM-IV diagnosis of schizophrenia, a history of resistance and/or intolerance to at least three acute cycles with different antipsychotics given at therapeutic doses, PANSS score >or=80, and CGI-S score >or=4...
Clinical Trials Related to Geodon (Ziprasidone)
Treatment of Schizophrenic Patients With Ziprasidone [Enrolling by invitation]
To determine whether ziprasidone provides good efficacy and tolerability in the treatment of
schizophrenic Greek patients.
Geodon (Ziprasidone) for Posttraumatic Stress Disorder [Completed]
Atypical antipsychotics have shown promise in the treatment of depression and anxiety, which
are prominent symptoms of PTSD. The profile of the atypical antipsychotic, ziprasidone
(Geodon), suggests possible anxiolytic and antidepressant properties. This research will
assess the potential effectiveness of Geodon in civilian men and women who suffer from severe
PTSD. Response to ziprasidone or placebo will be measured by Clinician Administered PTSD
Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8).
A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders [Completed]
The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in
children and teens with psychotic disorders
A Study of Ziprasidone for the Treatment of Psychosis in Patients Who Had Already Had Benefits From Ziprasidone Treatment in a Previous Study [Completed]
The purpose of this study is to evaluate the efficacy and tolerability of ziprasidone in
patients who successfully completed a study of ziprasidone treatment of psychosis (Protocol
A1281074).
A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis [Completed]
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Page last updated: 2009-11-19
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