A Study of Ziprasidone for the Treatment of Psychosis in Patients Who Had Already Had Benefits From Ziprasidone Treatment in a Previous Study

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00645320
First received: March 21, 2008
Last updated: April 7, 2008
Last verified: April 2008
  Purpose

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).


Condition Intervention Phase
Pyschotic Disorders
Drug: Ziprasidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Extension Study To Assess The Efficacy And Tolerability Of Oral Ziprasidone In Patients Successfully Completing A Previous Study With Ziprasidone

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in Clinical Global Impression-Severity (CGI-S) score [ Time Frame: Until Final Visit (within 3 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: Baseline and Months 1, 2, and 3 ] [ Designated as safety issue: Yes ]

Enrollment: 75
Study Start Date: August 2003
Study Completion Date: August 2004
Arms Assigned Interventions
Experimental: A Drug: Ziprasidone
Oral ziprasidone tablets 40 or 80 mg twice daily with meals for 3 months. Doses were flexible based on investigator's discretion.
Other Name: Geodon, Zeldox

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Psychotic disorder
  • Completion of previous study of intramuscular ziprasidone
  • Ability to continue with oral ziprasidone

Exclusion Criteria:

  • Concomitant treatment with other anti-psychotic agents within 12 hours prior to the enrollment; for depot agents, a period of two weeks or a cycle, whichever is longer, should occur between the last administration and the patient's enrollment.
  • Treatment with antidepressants or mood stabilizers within seven days prior to the enrollment; for MAOIs (monoamine oxidase inhibitors) and moclobemide, this period should be of two weeks; for fluoxetine, five weeks.
  • Resistance to conventional psychotic agents. (Resistance is defined as a failure to present a therapeutic response during the acute exacerbation after proper attempts of treatment with marketed antipsychotic agents in two or more occasions during the two years prior to the enrollment in the study.)
  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: NCT00645320

Locations
Brazil
Pfizer Investigational Site
Salvador, Bahia, Brazil, 41180-000
Pfizer Investigational Site
Fortaleza, Ceara, Brazil, 60175-270
Pfizer Investigational Site
Belo Horizonte, MG, Brazil, 30150-270
Pfizer Investigational Site
Curitiba, PR, Brazil
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil
Pfizer Investigational Site
Jardim Santa Monica Sn, Salvador - Ba, Brazil, 40340-720
Pfizer Investigational Site
Sao Paulo, SP, Brazil
Pfizer Investigational Site
Rio de Janeiro Rj, Brazil, 22640-100
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: NCT00645320     History of Changes
Other Study ID Numbers: A1281114
Study First Received: March 21, 2008
Last Updated: April 7, 2008
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 18, 2014