A Study of the Efficacy and Safety of Ziprasidone in Patients With Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

• ClinicalTrials.gov Identifier: NCT00645229
• Recruitment Status: Terminated
• First Posted: March 27, 2008
• Last Update Posted: April 10, 2008
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: March 25, 2008
• First Posted Date: March 27, 2008
• Last Update Posted Date: April 10, 2008
• Study Start Date: September 2004
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: March 25, 2008)

• Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 24 [ Time Frame: Week 24 ]
• Change from baseline in PANSS (Depression-C) score at Week 24 [ Time Frame: Week 24 ]
• Change from baseline in Clinical Global Impressions-Severity (CGI-S) total score at Week 24 [ Time Frame: Week 24 ]
• Change from baseline in CGI-S total score at Week 24 [ Time Frame: Week 24 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 25, 2008)

• 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 ]
• Change from baseline in Clinical Global Impressions-Improvement (CGI-I) score at Week 24 [ Time Frame: Week 24 ]
• 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 ]
• Change from baseline in Global Assessment of Functioning (GAF) score at Week 24 [ Time Frame: Week 24 ]
• 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 ]
• 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 ]
• 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 ]
• Electrocardiogram [ Time Frame: Screening and Month 4 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of the Efficacy and Safety of Ziprasidone in Patients With Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
• Official Title: Efficacy And Safety Of Ziprasidone In Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder, Including Patients With A Diagnosis Of Recent Onset
• 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
• 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
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Schizophrenia
• Schizoaffective Disorder

Intervention

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

Study Arms

Experimental: Arm A

Intervention: Drug: Ziprasidone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: March 25, 2008): 1
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 2005
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Portugal

Administrative Information

• NCT Number: NCT00645229
• Other Study ID Numbers: A1281055
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: April 2008