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Trial record 1 of 1 for:    NCT00649064
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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

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ClinicalTrials.gov Identifier: NCT00649064
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE March 28, 2008
First Posted Date  ICMJE April 1, 2008
Last Update Posted Date February 21, 2021
Study Start Date  ICMJE December 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
Change from baseline in Brief Psychiatric Rating Scale (BPRS) total score [ Time Frame: Week 6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Effects of Ziprasidone for the Treatment of Schizophrenia or Schizoaffective Disorder in Patients Who Were Switched From Other Antipsychotic Drugs
Official Title  ICMJE A Multi-Center Study To Examine The Clinical Effects Of Cross Titration Of Antipsychotics With Ziprasidone In Subjects With Schizophrenia Or Schizoaffective Disorder
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizoaffective Disorder
  • Schizophrenia
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Ziprasidone
Intervention: Drug: Ziprasidone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2008)
46
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00649064
Other Study ID Numbers  ICMJE A1281120
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP