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

• ClinicalTrials.gov Identifier: NCT00650429
• Recruitment Status: Completed
• First Posted: April 1, 2008
• Last Update Posted: February 21, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information

• First Submitted Date: March 28, 2008
• First Posted Date: April 1, 2008
• Last Update Posted Date: February 21, 2021
• Study Start Date: October 2003
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: March 28, 2008): 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) ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 28, 2008)

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

• 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 for the Treatment of Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
• Official Title: Ziprasidone Intramuscular/Oral In The Treatment Of Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder: A Six-Week Open Administration Study
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Schizophrenia
• Schizoaffective Disorder

Intervention

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

Study Arms

Experimental: Arm A

Intervention: Drug: Ziprasidone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 28, 2008): 28
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 2005
• Primary Completion Date: Not Provided

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Mexico

Administrative Information

• NCT Number: NCT00650429
• Other Study ID Numbers: A1281056
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
• Study Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Collaborators: Not Provided

Investigators

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

• PRS Account: Pfizer
• Verification Date: February 2021