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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00650429
First received: March 28, 2008
Last updated: April 7, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Schizophrenia
Schizoaffective Disorder
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: Ziprasidone Intramuscular/Oral In The Treatment Of Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder: A Six-Week Open Administration Study

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Simpson-Angus Scale (SAS) [ Time Frame: Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO) ] [ Designated as safety issue: Yes ]
  • Barnes Akathisia Scale (BAS) [ Time Frame: Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO) ] [ Designated as safety issue: Yes ]
  • Laboratory tests [ Time Frame: Screening and Week 6 ] [ Designated as safety issue: Yes ]
  • Electrocardiogram [ Time Frame: Screening and Week 6 ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) ] [ Designated as safety issue: Yes ]
  • Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Day 1 (IM), Day 4 (Switch), and Week 6 (PO) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: October 2003
Study Completion Date: May 2005
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  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: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00650429     History of Changes
Other Study ID Numbers: A1281056
Study First Received: March 28, 2008
Last Updated: April 7, 2008
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

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

ClinicalTrials.gov processed this record on November 20, 2014