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A Study of the Efficacy and Safety of Ziprasidone for the Treatment of Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

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ClinicalTrials.gov Identifier: NCT00650429
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 October 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
Change from baseline to endpoint in Brief Psychiatric Rating Scale (BPRS) total score [ Time Frame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
  • Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale score [ Time Frame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) ]
  • Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scale score [ Time Frame: Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) ]
  • Simpson-Angus Scale (SAS) [ Time Frame: Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO) ]
  • Barnes Akathisia Scale (BAS) [ Time Frame: Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO) ]
  • Laboratory tests [ Time Frame: Screening and Week 6 ]
  • Electrocardiogram [ Time Frame: Screening and Week 6 ]
  • Adverse events [ Time Frame: Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) ]
  • Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Day 1 (IM), Day 4 (Switch), and Week 6 (PO) ]
  • Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) ]
  • Change from baseline to endpoint in Covi Anxiety Scale score [ Time Frame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) ]
  • Change from baseline to endpoint in Positive PANSS subscale score [ Time Frame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) ]
  • Change from baseline to endpoint in Negative PANSS subscale score [ Time Frame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) ]
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 for the Treatment of Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
Official Title  ICMJE Ziprasidone Intramuscular/Oral In The Treatment Of Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder: A Six-Week Open Administration Study
Brief Summary This study was conducted to examine the efficacy and tolerability of ziprasidone intramuscular (IM), and to assess the effect of switching from IM to oral ziprasidone for the treatment of acute exacerbation of schizophrenia and schizoaffective disorder in a Latin American population.
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
  • Schizophrenia
  • Schizoaffective Disorder
Intervention  ICMJE Drug: Ziprasidone
IM ziprasidone at an initial dose of 10 or 20 mg for the first 3 days; additional doses could be administered according to clinical need, with the maximum total daily IM dose of 40 mg. On Day 4, IM treatment was switched to oral (PO) treatment at an initial dose of 40 mg twice daily for the first 2 days; doses could be subsequently adjusted within the range of 40 to 80 mg twice daily. Total treatment duration was 6 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 Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2008)
28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder.
  • Inpatients with acute exacerbation of psychotic symptoms.
  • Patients with a minimum score of 40 on the BPRS scale (1-7).

Exclusion Criteria:

  • Concurrent treatment with antipsychotic agents at study drug initiation (within 12 hours prior to study drug initiation); for depot agents a period of two weeks or one cycle, whichever is the longer, must occur between last administration and study drug initiation.
  • Treatment with antidepressants or mood stabilizers within 7 days of start of ziprasidone.
  • Patients currently receiving clozapine.
  • Patients at immediate risk of committing harm to self or others.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 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 Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00650429
Other Study ID Numbers  ICMJE A1281056
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