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

Phase 4

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Drug: Ziprasidone

• Registration Number: NCT00650429
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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 available

Study Timeline

• Study Start: 2003-10
• Study Completion: 2005-05
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-03-28
• Study First Posted: 2008-04-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	Ziprasidone	-

Primary Outcome Measures

Name	Time	Method
Change from baseline to endpoint in Brief Psychiatric Rating Scale (BPRS) total score	Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)

Secondary Outcome Measures

Name	Time	Method
Electrocardiogram	Screening and Week 6
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale score	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	Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Simpson-Angus Scale (SAS)	Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO)
Barnes Akathisia Scale (BAS)	Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO)
Laboratory tests	Screening and Week 6
Adverse events	Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Abnormal Involuntary Movement Scale (AIMS)	Day 1 (IM), Day 4 (Switch), and Week 6 (PO)
Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total score	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	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	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	Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇲🇽 Mexico D F, Mexico