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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

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

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Ziprasidone Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy And Safety Of Ziprasidone In Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder, Including Patients With A Diagnosis Of Recent Onset
Study Start Date : September 2004
Study Completion Date : March 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
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



Primary Outcome Measures :
  1. Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 24 [ Time Frame: Week 24 ]
  2. Change from baseline in PANSS (Depression-C) score at Week 24 [ Time Frame: Week 24 ]
  3. Change from baseline in Clinical Global Impressions-Severity (CGI-S) total score at Week 24 [ Time Frame: Week 24 ]
  4. Change from baseline in CGI-S total score at Week 24 [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change from baseline in Clinical Global Impressions-Improvement (CGI-I) score at Week 24 [ Time Frame: Week 24 ]
  3. 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 ]
  4. Change from baseline in Global Assessment of Functioning (GAF) score at Week 24 [ Time Frame: Week 24 ]
  5. 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 ]
  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 ]
  7. 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 ]
  8. Electrocardiogram [ Time Frame: Screening and Month 4 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00645229


Locations
Portugal
Pfizer Investigational Site
Lisboa, Portugal, 1600-219
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: NCT00645229     History of Changes
Other Study ID Numbers: A1281055
First Posted: March 27, 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