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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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.
Pfizer Investigational Site
Monterrey, Nuevo León, Mexico
Pfizer Investigational Site
DF, Mexico
Pfizer Investigational Site
Mexico City, Mexico
Pfizer Investigational Site
Mexico D F, Mexico
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)
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)
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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)