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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00454883
First received: March 29, 2007
Last updated: November 18, 2008
Last verified: November 2008
  Purpose

Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.


Condition Intervention Phase
Affective Psychosis, Bipolar
Mania
Manic-Depressive Psychosis
Drug: ziprasidone
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Clinical global impression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Recording of extrapyramidal symptoms [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Changes in manic symptoms over course of treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of disease [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 379
Study Start Date: April 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454883

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00454883     History of Changes
Other Study ID Numbers: A1281159
Study First Received: March 29, 2007
Last Updated: November 18, 2008
Health Authority: Slovakia: State Institute for Drug Control

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:
Affective Disorders, Psychotic
Bipolar Disorder
Depressive Disorder, Major
Disease
Mental Disorders
Psychotic Disorders
Depressive Disorder
Mood Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Ziprasidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 27, 2014