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A Study of the Effects of Ziprasidone for the Treatment of Schizophrenia or Schizoaffective Disorder in Patients Who Were Switched From Other Antipsychotic Drugs

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00649064
First Posted: April 1, 2008
Last Update Posted: April 10, 2008
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.
Information provided by:
Pfizer
  Purpose
The purpose of this study is to see if differences exist in outcome in patients with schizophrenia or schizoaffective disorder who were switched from other antipsychotics to ziprasidone.

Condition Intervention Phase
Schizoaffective Disorder Schizophrenia Drug: Ziprasidone Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center Study To Examine The Clinical Effects Of Cross Titration Of Antipsychotics With Ziprasidone In Subjects With Schizophrenia Or Schizoaffective Disorder

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in Brief Psychiatric Rating Scale (BPRS) total score [ Time Frame: Week 6 ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: Weeks 1, 2, and 6 ]
  • Change from baseline in weight [ Time Frame: Baseline and Week 6 ]
  • Change from baseline in prolactin and lipid levels [ Time Frame: Baseline and Week 6 ]
  • Change from baseline in electrocardiogram [ Time Frame: Baseline and Week 6 ]
  • Change from baseline in Positive and Negative Symptom Scale (PANSS), including PANSS total scores and PANSS positive, PANSS negative, and PANSS general subscale scores [ Time Frame: Baseline and Weeks 1, 2, and 6 ]
  • Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores [ Time Frame: Baseline and Weeks 1, 2, and 6 ]
  • Clinical Global Impressions-Improvement (CGI-I) scale scores [ Time Frame: Baseline (using historical data) and Weeks 1, 2, and 6 ]
  • Change from baseline in movement disorder rating scales, including Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline and Week 6 ]
  • Change from baseline in vital signs [ Time Frame: Baseline and Weeks 1, 2, and 6 ]
  • Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) scores [ Time Frame: Baseline and Week 6 ]

Enrollment: 46
Study Start Date: December 2003
Study Completion Date: September 2004
Arms Assigned Interventions
Experimental: Ziprasidone Drug: Ziprasidone
Ziprasidone 40 mg capsules twice daily for the first 7 days followed by flexible dosing between 40 and 80 mg twice daily for the remaining 5 weeks.
Other Name: Geodon, Zeldox

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Outpatients for at least 3 months on treatment with sulpiride, olanzapine, quetiapine, or risperidone and at least a partial beneficial response to typical antipsychotic treatment including for the current episode
  • Partial improvement in symptoms that justified a switch to ziprasidone

Exclusion Criteria:

  • Diagnosis of major depression or occurrence of moderate depressive symptoms
  • Resistance to conventional antipsychotic drugs
  • Treatment with other drugs such as antiseizure medications, antipsychotics, antidepressants, or mood stabilizing agents that might interfere with the assessement of the efficacy of ziprasidone
  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): NCT00649064


Locations
Taiwan
Pfizer Investigational Site
Changhua, Taiwan
Pfizer Investigational Site
Tainan, Taiwan
Pfizer Investigational Site
Taipei, Taiwan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00649064     History of Changes
Other Study ID Numbers: A1281120
First Submitted: March 28, 2008
First Posted: April 1, 2008
Last Update Posted: April 10, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Ziprasidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents