Geodon Improves Depressive Symptoms in Patients With Bipolar Disorder and Schizophrenia, Studies

Main Category: Psychology / Psychiatry
Article Date: 08 Jun 2005 - 9:00 PDT

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Data from two separate studies conducted with Pfizer Inc's atypical antipsychotic Geodon® (ziprasidone HCl) showed the medication improved depressive symptoms in patients with bipolar disorder who had dysphoric mania [i] (a condition involving both manic and depressive symptoms) and in patients with schizophrenia. [ii] The studies were presented at the American Psychiatric Association's annual meeting.

Symptoms of depression are wide ranging and can include feelings of sadness, loss of energy, decreased activity, and difficulty concentrating or making decisions. These symptoms are often experienced by patients who have schizophrenia or bipolar disorder with dysphoric mania. The prevalence of depressive symptoms in patients with schizophrenia is high, at 50 percent to 80 percent. It is also not well controlled [iii] and is associated with more relapses and poorer outcomes. [iv] Depressive symptoms associated with dysphoric mania in bipolar patients are potentially severe and difficult to treat. The use of standard antidepressants alone is generally not appropriate, as these medications may worsen manic symptom severity.

"These studies suggest that Geodon can relieve depressive symptoms that may occur as one of the many symptoms of schizophrenia and bipolar mania, in addition to its clear effectiveness in treating psychotic and manic symptoms," said Nina Schooler, Ph.D., adjunct professor, Georgetown University School of Medicine.

Study of Geodon's Efficacy in Dysphoric Mania in Bipolar Disorder

An analysis was conducted of pooled data from three, double-blind studies involving Geodon use by patients with bipolar mania who also had dysphoria or depressive symptoms. Patients given Geodon showed significantly more rapid and consistent improvements in depressive symptoms than those given placebo or the antipsychotic haloperidol (Haldol). On a standard rating scale for depression, patients given Geodon showed significant improvements versus placebo starting at day four of treatment and at all subsequent visits; those given haloperidol did not show statistically significant improvement at the study end point.

Study of Geodon's Efficacy in Depressive Symptoms Associated with Schizophrenia

In this study, patients with schizophrenia who took Geodon demonstrated improvements in depressive symptoms and had high rates of response after switching from other antipsychotics to long-term treatment with Geodon.

The presentation was based on pooled data from 63 patients who completed one-year extensions of three separate, six-week studies in which they were switched to flexibly-dosed Geodon (40-160 mg per day) from a previous antipsychotic -- either a conventional antipsychotic (such as chlorpromazine or haloperidol), or one of two second-generation antipsychotics, olanzapine (Zyprexa®) or risperidone (Risperdal®).

After one year, the average scores of the patients significantly improved on a standard measure of depression. Treatment response to Geodon, defined by a 50 percent or greater improvement on the depression scale used in this study, was achieved by 60 percent of patients who previously were taking conventional antipsychotics and 63 percent of patients who formerly used olanzapine or risperidone.

About Geodon

Approved in the United States in February 2001 for the treatment of schizophrenia and in 2004 for acute bipolar mania, Geodon is licensed in 73 countries, and more than 5 million prescriptions have been written worldwide. It is widely accepted on hospital, Medicaid, national Veterans Administration (VA) and managed care formularies.

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Geodon is not approved for the treatment of elderly patients with dementia-related psychosis.

Geodon is contraindicated in patients with a known history of QT prolongation, recent acute myocardial infarction, or uncompensated heart failure, and should not be used with other QT-prolonging drugs.

Geodon has a greater capacity to prolong the QTc interval than several antipsychotics. With some drugs, QT prolongation has been associated with torsade de pointes, a potentially fatal arrhythmia.

Hyperglycemia related adverse events, sometimes serious, have been reported in patients treated with atypical antipsychotics. There have been few reports of hyperglycemia or diabetes in patients treated with Geodon, and it is not known if Geodon is associated with these events. Patients treated with an atypical antipsychotic should be monitored for symptoms of hyperglycemia.

Discovered and developed by Pfizer, Geodon is a serotonin and dopamine antagonist. In short-term trials, the most commonly observed side effects were somnolence and respiratory distress, of which more than 90 percent were cold symptoms or upper respiratory infections.

Full Geodon prescribing information is available at www.geodon.com.

[i] Zajecka J, Murray S, Ramey T, Mandel F. Efficacy of ziprasidone in dysphoric mania. Session # 6, final program #328: presentation at: 158th annual meeting of the American Psychiatric Association, Atlanta, GA, May 21-26, 2005.

[ii] Schooler NR, Loebel A, Yang R. Longterm depressive symptom improvement after switch to ziprasidone. Session # 5, final program #168: presentation at: 158th annual meeting of the American Psychiatric Association, Atlanta, GA, May 21-26, 2005.

[iii] Schooler NR, Buckley PF, Harvey PD, Weiden PJ. Optimizing treatment of schizophrenia. Enhancing affective/cognitive and depressive functioning. CNS Spectr. 2005;10 (suppl 2):1-16.

[iv] Schooler NR, Buckley PF, Harvey PD, Weiden PJ. Optimizing treatment of schizophrenia. Enhancing affective/cognitive and depressive functioning. CNS Spectr. 2005;10 (suppl 2):1-16.

Brianne Donahue
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