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Trial record 1 of 1 for:    NCT00649064
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A Study of the Effects of Ziprasidone for the Treatment of Schizophrenia or Schizoaffective Disorder in Patients Who Were Switched From Other Antipsychotic Drugs

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. Identifier: NCT00649064
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : February 21, 2021
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Brief Summary:
The purpose of this study is to see if differences exist in outcome in patients with schizophrenia or schizoaffective disorder who were switched from other antipsychotics to ziprasidone.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center Study To Examine The Clinical Effects Of Cross Titration Of Antipsychotics With Ziprasidone In Subjects With Schizophrenia Or Schizoaffective Disorder
Study Start Date : December 2003
Actual Study Completion Date : September 2004

Arm Intervention/treatment
Experimental: Ziprasidone Drug: Ziprasidone
Ziprasidone 40 mg capsules twice daily for the first 7 days followed by flexible dosing between 40 and 80 mg twice daily for the remaining 5 weeks.
Other Name: Geodon, Zeldox

Primary Outcome Measures :
  1. Change from baseline in Brief Psychiatric Rating Scale (BPRS) total score [ Time Frame: Week 6 ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Weeks 1, 2, and 6 ]
  2. Change from baseline in weight [ Time Frame: Baseline and Week 6 ]
  3. Change from baseline in prolactin and lipid levels [ Time Frame: Baseline and Week 6 ]
  4. Change from baseline in electrocardiogram [ Time Frame: Baseline and Week 6 ]
  5. Change from baseline in Positive and Negative Symptom Scale (PANSS), including PANSS total scores and PANSS positive, PANSS negative, and PANSS general subscale scores [ Time Frame: Baseline and Weeks 1, 2, and 6 ]
  6. Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores [ Time Frame: Baseline and Weeks 1, 2, and 6 ]
  7. Clinical Global Impressions-Improvement (CGI-I) scale scores [ Time Frame: Baseline (using historical data) and Weeks 1, 2, and 6 ]
  8. Change from baseline in movement disorder rating scales, including Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline and Week 6 ]
  9. Change from baseline in vital signs [ Time Frame: Baseline and Weeks 1, 2, and 6 ]
  10. Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) scores [ Time Frame: Baseline and Week 6 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Outpatients for at least 3 months on treatment with sulpiride, olanzapine, quetiapine, or risperidone and at least a partial beneficial response to typical antipsychotic treatment including for the current episode
  • Partial improvement in symptoms that justified a switch to ziprasidone

Exclusion Criteria:

  • Diagnosis of major depression or occurrence of moderate depressive symptoms
  • Resistance to conventional antipsychotic drugs
  • Treatment with other drugs such as antiseizure medications, antipsychotics, antidepressants, or mood stabilizing agents that might interfere with the assessement of the efficacy of ziprasidone

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 identifier (NCT number): NCT00649064

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Pfizer Investigational Site
Changhua, Taiwan
Pfizer Investigational Site
Tainan, Taiwan
Pfizer Investigational Site
Taipei, Taiwan
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Identifier: NCT00649064    
Other Study ID Numbers: A1281120
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
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