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Trial record 1 of 1 for:    NCT00645229
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A Study of the Efficacy and Safety of Ziprasidone in Patients With Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

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.
 
ClinicalTrials.gov Identifier: NCT00645229
Recruitment Status : Terminated (Please see Detailed Description for termination reason.)
First Posted : March 27, 2008
Last Update Posted : April 10, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 25, 2008
First Posted Date  ICMJE March 27, 2008
Last Update Posted Date April 10, 2008
Study Start Date  ICMJE September 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2008)
  • Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 24 [ Time Frame: Week 24 ]
  • Change from baseline in PANSS (Depression-C) score at Week 24 [ Time Frame: Week 24 ]
  • Change from baseline in Clinical Global Impressions-Severity (CGI-S) total score at Week 24 [ Time Frame: Week 24 ]
  • Change from baseline in CGI-S total score at Week 24 [ Time Frame: Week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2008)
  • Vital signs and weight at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 [ Time Frame: Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 ]
  • Change from baseline in Clinical Global Impressions-Improvement (CGI-I) score at Week 24 [ Time Frame: Week 24 ]
  • Adverse events on Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 [ Time Frame: Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 ]
  • Change from baseline in Global Assessment of Functioning (GAF) score at Week 24 [ Time Frame: Week 24 ]
  • Laboratory parameters at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 [ Time Frame: Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 ]
  • Simpson-Angus Scale (SAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 [ Time Frame: Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 ]
  • Barnes Akathisia Scale (BAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 [ Time Frame: Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 ]
  • Electrocardiogram [ Time Frame: Screening and Month 4 ]
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 Efficacy and Safety of Ziprasidone in Patients With Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
Official Title  ICMJE Efficacy And Safety Of Ziprasidone In Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder, Including Patients With A Diagnosis Of Recent Onset
Brief Summary The purpose of this study is to evaluate the efficacy and safety of ziprasidone in acute exacerbation of schizophrenia or schizoaffective disorder, including patients with recent onset of symptoms
Detailed Description The study was prematurely discontinued due to the difficulty of subject recruitment on March 24, 2005. There were no safety concerns that led to the decision to terminate.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
Intervention  ICMJE Drug: Ziprasidone
Ziprasidone 20 mg capsules twice daily on Days 1-3; dose could be increased if clinically indicated up to 80 mg twice daily; total treatment duration was to be 24 weeks
Other Name: Geodon, Zeldox
Study Arms  ICMJE Experimental: Arm A
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 Terminated
Actual Enrollment  ICMJE
 (submitted: March 25, 2008)
1
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients not currently being treated with antipsychotic medication and neuroleptic naive patients
  • Diagnosis of schizophrenia or schizoaffective disorder
  • Antipsychotic treatment prior to screening was to be for a cumulative period of less than 5 years

Exclusion Criteria:

  • Patients at immediate risk of committing harm to self or others
  • Treatment with clozapine within 3 months prior to baseline
  • History of neuroleptic treatment
  • Current antipsychotic treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Portugal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00645229
Other Study ID Numbers  ICMJE A1281055
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2008

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