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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 : April 10, 2008
Sponsor:
Information provided by:
Pfizer

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Ziprasidone Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ziprasidone Intramuscular/Oral In The Treatment Of Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder: A Six-Week Open Administration Study
Study Start Date : October 2003
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm A 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



Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. Simpson-Angus Scale (SAS) [ Time Frame: Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO) ]
  4. Barnes Akathisia Scale (BAS) [ Time Frame: Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO) ]
  5. Laboratory tests [ Time Frame: Screening and Week 6 ]
  6. Electrocardiogram [ Time Frame: Screening and Week 6 ]
  7. Adverse events [ Time Frame: Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) ]
  8. Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Day 1 (IM), Day 4 (Switch), and Week 6 (PO) ]
  9. 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) ]
  10. 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) ]
  11. 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) ]
  12. 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) ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT00650429


Locations
Mexico
Pfizer Investigational Site
Monterrey, Nuevo Leon, Mexico, 64800
Pfizer Investigational Site
DF, Mexico, 14420
Pfizer Investigational Site
Mexico City, Mexico, 14050
Pfizer Investigational Site
Mexico D F, Mexico, 14269
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00650429     History of Changes
Other Study ID Numbers: A1281056
First Posted: April 1, 2008    Key Record Dates
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
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents