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Non-interventional Study of Ziprasidone in the Treatment of Bipolar and Schizoaffective Disorders.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00454883
Recruitment Status : Completed
First Posted : April 2, 2007
Last Update Posted : July 2, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.

Condition or disease Intervention/treatment
Affective Psychosis, Bipolar Mania Manic-Depressive Psychosis Drug: ziprasidone

Detailed Description:
Method: Consecutive patient sampling. Patients were included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.

Study Design

Study Type : Observational
Actual Enrollment : 379 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment Of Manic Or Mixed Episodes Of Up To Moderate Severity In Patients With Bipolar Disorder And Schizoaffective Disorder
Study Start Date : April 2007
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
1 cohort of patients treated with ziprasidone Drug: ziprasidone
Ziprasidone 40 mg twice daily taken with food. Daily dosage may subsequently be adjusted on the basis of individual clinical status up to a maximum of 80 mg twice daily. If indicated, the maximum recommended dose may be reached as early as day 3 of treatment.
Other Name: Geodon, Zeldox

Outcome Measures

Primary Outcome Measures :
  1. Clinical global impression [ Time Frame: 3 months ]
  2. Recording of extrapyramidal symptoms [ Time Frame: 3 months ]
  3. Changes in manic symptoms over course of treatment [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Severity of disease [ Time Frame: 3 months ]
  2. Adverse Events [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients were identified in in- and outpatients settings (university departments, hospital wards, outpatients clinics, daily psychiatric hospitals)

Inclusion Criteria:

  • Manic and mixed episodes of up to moderate severity in patients with Type I and II bipolar disorder and schizoaffective disorder; either first diagnosed or repeated episodes

Exclusion Criteria:

  • Hypersensitivity to ziprasidone
  • prolonged QTc interval
  • coadministration with substances that are prolonging the QTc interval
  • recent acute MI, cardiac failure, patients with arrhythmias treated with class IA or III medicaments
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454883

Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00454883     History of Changes
Other Study ID Numbers: A1281159
First Posted: April 2, 2007    Key Record Dates
Last Update Posted: July 2, 2015
Last Verified: June 2015

Keywords provided by Pfizer:
Safety of ziprasidone, efficacy of ziprasidone, manic episodes in bipolar disorder, mixed episodes in bipolar disorder, schizoaffective disorder.

Additional relevant MeSH terms:
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Affective Disorders, Psychotic
Bipolar and Related Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents