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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00649064
First received: March 28, 2008
Last updated: April 7, 2008
Last verified: April 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: Weeks 1, 2, and 6 ] [ Designated as safety issue: Yes ]
  • Change from baseline in weight [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: Yes ]
  • Change from baseline in prolactin and lipid levels [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: Yes ]
  • Change from baseline in electrocardiogram [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores [ Time Frame: Baseline and Weeks 1, 2, and 6 ] [ Designated as safety issue: No ]
  • Clinical Global Impressions-Improvement (CGI-I) scale scores [ Time Frame: Baseline (using historical data) and Weeks 1, 2, and 6 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Change from baseline in vital signs [ Time Frame: Baseline and Weeks 1, 2, and 6 ] [ Designated as safety issue: Yes ]
  • Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) scores [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00649064     History of Changes
Other Study ID Numbers: A1281120
Study First Received: March 28, 2008
Last Updated: April 7, 2008
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on October 01, 2014