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)
Schizophrenia 'Guideline of Guidelines' Released Source: Medscape Psychiatry & Mental Health Headlines [2013.05.16] New "meta-guidelines" combining recommendations from several expert organizations on the management and treatment of schizophrenia have been released. Medscape Medical News
Model Cell System Offers Insights Into Epilepsy, Schizophrenia, Other Neuropsych Disorders Source: Autism News From Medical News Today [2013.05.06] Medical researchers have manipulated human stem cells into producing types of brain cells known to play important roles in neurodevelopmental disorders such as epilepsy, schizophrenia and autism...
Neurons In The Nose Could Be The Key To Early, Fast, And Accurate Diagnosis Of Schizophrenia Source: Schizophrenia News From Medical News Today [2013.05.01] A debilitating mental illness, schizophrenia can be difficult to diagnose. Because physiological evidence confirming the disease can only be gathered from the brain during an autopsy, mental health professionals have had to rely on a battery of psychological evaluations to diagnose their patients. Now, Dr. Noam Shomron and Prof...
Schizophrenia May Be Diagnosed By Testing Nerve Cells From The Nose Source: Schizophrenia News From Medical News Today [2013.05.01] Collecting neurons from the nose could be a fast way to test for schizophrenia, a debilitating mental illness that is often difficult to diagnose. This was the finding of a new study led by researchers from Tel Aviv University (TAU) in Israel...
The Dual Role Of Testosterone In Schizophrenia Source: Endocrinology News From Medical News Today [2013.04.30] Researchers from Neuroscience Research Australia (NeuRA) have presented new results about the role of testosterone in schizophrenia at the International Congress on Schizophrenia Research being held in Orlando, Florida. They have found that, on the one hand, testosterone could be the trigger for the onset of schizophrenia...
Published Studies Related to Geodon (Ziprasidone)
Predictors of response to ziprasidone: results from a 6-week randomized
double-blind, placebo-controlled trial for acute depressive mixed state. [2012] response to ziprasidone in a sample of patients with mixed depressive state... CONCLUSIONS: Further investigations are warranted due to clear limitations,
Ziprasidone with adjunctive mood stabilizer in the maintenance treatment of
bipolar I disorder: long-term changes in weight and metabolic profiles. [2012] This analysis was conducted to compare the effects of adjunctive ziprasidone or
placebo on metabolic parameters among patients receiving maintenance treatment
with lithium or valproate. We also tested whether metabolic syndrome (MetS) and
other risk factors were associated with baseline characteristics and treatment
response...
Efficacy and safety of adjunctive oral ziprasidone for acute treatment of depression in patients with bipolar I disorder: a randomized, double-blind, placebo-controlled trial. [2011.10] CONCLUSIONS: Adjunctive ziprasidone treatment failed to separate from mood stabilizer alone on primary and secondary endpoints. Possible contributions to this result include enrollment of a substantial number of subjects with low diagnostic confidence, low quality ratings on the MADRS, and overzealous reporting of symptoms by subjects. TRIAL REGISTRATION: clinical trials.gov Identifier: NCT00483548. (c) Copyright 2011 Physicians Postgraduate Press, Inc.
Performance and interview-based assessments of cognitive change in a randomized, double-blind comparison of lurasidone vs. ziprasidone. [2011.04] BACKGROUND: Improving cognitive functioning in people with schizophrenia is a major treatment goal. In addition, interview-based measures have been developed to supplement performance-based assessments. However, few data are available regarding whether interview-based measures are sensitive to treatment-related changes... CONCLUSIONS: These data suggest that interview-based cognitive measures such as the SCoRS may be sensitive to changes after 3weeks of treatment in patients with schizophrenia. Lurasidone is being assessed further in ongoing clinical trials with additional outcome measures. Copyright (c) 2011 Elsevier B.V. All rights reserved.
Ziprasidone vs olanzapine in recent-onset schizophrenia and schizoaffective disorder: results of an 8-week double-blind randomized controlled trial. [2011.03] 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.
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]
Reports of Suspected Geodon (Ziprasidone) Side Effects
Drug Ineffective (64),
Feeling Abnormal (64),
Somnolence (61),
Depression (55),
Malaise (52),
Insomnia (52),
Weight Increased (46),
Anxiety (43),
Tremor (41),
Fatigue (38), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Geodon has an overall score of 10. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | Geodon review by 39 year old female patient | | | Rating |
| Overall rating: | |           |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | | Treatment Info |
| Condition / reason: | | bi-polar disorder |
| Dosage & duration: | | 80 mg taken 2x/daily for the period of 3 yrs. |
| Other conditions: | | OCD, Post Traumatic Stress Disorder, Panic/Anxiety attacks |
| Other drugs taken: | | hydrocodone, esgic plus tabs | | | Reported Results |
| Benefits: | | The benefits are numerous. With the Geodon I haven't suffered from a bout of depression in app. 2 1/2 yrs.. Before the Geodon I suffered from depression for months at a time. I haven't been or felt suicidal at all since beginning the drug. With Geodon I am on an even keel. By that I mean that I do not suffer from the peaks and valleys of typical bi-polar disorder. I no longer have manic episodes for days and then sink into a dark depression. It has made most of my bi-polar traits go away. |
| Side effects: | | The side effects are: dry mouth, possible headache, |
| Comments: | | The treatment for me is to take 2 80mg capsules of Geodon daily and follow up with a psychiatrist. |
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| | Geodon review by 39 year old female patient | | | Rating |
| Overall rating: | |           |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | | Treatment Info |
| Condition / reason: | | bi-polar disorder |
| Dosage & duration: | | 80 mg taken 2x/daily for the period of 3 yrs. |
| Other conditions: | | OCD, Post Traumatic Stress Disorder, Panic/Anxiety attacks |
| Other drugs taken: | | hydrocodone, esgic plus tabs | | | Reported Results |
| Benefits: | | The benefits are numerous. With the Geodon I haven't suffered from a bout of depression in app. 2 1/2 yrs.. Before the Geodon I suffered from depression for months at a time. I haven't been or felt suicidal at all since beginning the drug. With Geodon I am on an even keel. By that I mean that I do not suffer from the peaks and valleys of typical bi-polar disorder. I no longer have manic episodes for days and then sink into a dark depression. It has made most of my bi-polar traits go away. |
| Side effects: | | The side effects are: dry mouth, possible headache, |
| Comments: | | The treatment for me is to take 2 80mg capsules of Geodon daily and follow up with a psychiatrist. |
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Page last updated: 2013-05-16
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