A Study Comparing the Efficacy and Safety of Ziprasidone and Aripiprazole for the Treatment fo Schizophrenia or Schizoaffective Disorder in Hospitalized Patients
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the efficacy and safety of ziprasidone and aripiprazole in hospitalized patients with schizophrenia or schizoaffective disorder
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Aripiprazole
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Drug: Aripiprazole
Oral aripiprazole capsules 15 mg once daily from Days 1-14; thereafter, doses could be adjusted on Days 14 and 21 to 10, 15, or 30 mg once daily; patients treated for 28 days
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Active Comparator: Ziprasidone
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Drug: Ziprasidone
Oral ziprasidone capsules 40 mg twice daily on Day 1, 60 mg twice daily on Day 2, 80 mg twice daily on Days 3-14; thereafter, doses could be adjusted on Days 14 and 21 to 40, 60, or 80 mg twice daily; patients treated for 28 days
|
Outcome Measures
Primary Outcome Measures
- Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores. [28 days]
- Change from baseline to endpoint in Brief Psychiatric Rating Scale derived (BPRSd) total scores. [28 days]
Secondary Outcome Measures
- Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Positive and Negative Syndrome Scale (PANSS) positive subscale scores. [28 days]
- Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS negative subscale scores. [28 days]
- Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS Depression factor scores. [28 days]
- Change from baseline to endpoint in Calgary Depression Scale for Schizophrenia (CDSS) scores. [28 days]
- Change from baseline to Days 2, 4, 7, 14, 21, and 28 in COVI Anxiety Scale scores. [28 days]
- Change from baseline to endpoint in Global Assessment of Functioning (GAF) scale scores. [28 days]
- Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores. [28 days]
- Change from baseline to endpoint in Personal Evaluation of Transition in Treatment (PETiT) scale scores. [28 days]
- Change from baseline to endpoint in Patient Preference Scale (PPS) scores. [28 days]
- Change from baseline to endpoint in Life Skills Profile (LSP). [28 days]
- Change from baseline in Outcome Resource Discharge Questionnaire (ORDQ) scores on Days 2, 4, 7, 14, 21, and 28. [28 days]
- Change from baseline to endpoint in Cognitive Battery. [28 days]
- Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS total scores. [28 days]
- Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Clinical Global Impressions-Improvement (CGI-I) scale scores. [28 days]
- Adverse events, laboratory evaluations, vital signs, electrocardiograms at baseline and on Days 2, 4, 7, 14, 21, and 28. [28 days]
- Change from baseline to Day 28 in movement disorder rating scale scores. [28 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Hospitalized patients with schizophrenia or schizoaffective disorder
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At least a 6th grade reading level
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Males or females, between 18 and 70 years of age at the time of consent
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Subjects must have been hospitalized for no more than 14 consecutive days immediately prior to screening
Exclusion Criteria:
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Psychiatric disorder other than schizophrenia or schizoaffective disorder
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History of arrhythmia, heart attack, or heart failure
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Pfizer Investigational Site | Anaheim | California | United States | 92804 |
2 | Pfizer Investigational Site | Cerritos | California | United States | 90703 |
3 | Pfizer Investigational Site | Culver City | California | United States | 90232 |
4 | Pfizer Investigational Site | Garden Grove | California | United States | 92845 |
5 | Pfizer Investigational Site | Glendale | California | United States | 91206 |
6 | Pfizer Investigational Site | La Mesa | California | United States | 91942 |
7 | Pfizer Investigational Site | Newport Beach | California | United States | 92663 |
8 | Pfizer Investigational Site | Paramount | California | United States | 90723 |
9 | Pfizer Investigational Site | Riverside | California | United States | 92506 |
10 | Pfizer Investigational Site | San Diego | California | United States | 92105 |
11 | Pfizer Investigational Site | San Diego | California | United States | 92123 |
12 | Pfizer Investigational Site | San Diego | California | United States | 92126 |
13 | Pfizer Investigational Site | Torrance | California | United States | 90505 |
14 | Pfizer Investigational Site | Upland | California | United States | 91786 |
15 | Pfizer Investigational Site | Washington | District of Columbia | United States | 20016 |
16 | Pfizer Investigational Site | Hialeah | Florida | United States | 33016 |
17 | Pfizer Investigational Site | Shreveport | Louisiana | United States | 71101 |
18 | Pfizer Investigational Site | Baltimore | Maryland | United States | 21202 |
19 | Pfizer Investigational Site | Rockville | Maryland | United States | 20850 |
20 | Pfizer Investigational Site | Saint Louis | Missouri | United States | 63104 |
21 | Pfizer Investigational Site | Saint Louis | Missouri | United States | 63118 |
22 | Pfizer Investigational Site | Clementon | New Jersey | United States | 08021 |
23 | Pfizer Investigational Site | Princeton | New Jersey | United States | 08540 |
24 | Pfizer Investigational Site | Westampton | New Jersey | United States | 08060 |
25 | Pfizer Investigational Site | Willingboro | New Jersey | United States | 08046 |
26 | Pfizer Investigational Site | Jamaica | New York | United States | 11418 |
27 | Pfizer Investigational Site | Staten Island | New York | United States | 10305 |
28 | Pfizer Investigational Site | Butner | North Carolina | United States | 27509 |
29 | Pfizer Investigational Site | Chapel Hill | North Carolina | United States | 27599-7160 |
30 | Pfizer Investigational Site | Durham | North Carolina | United States | 27705 |
31 | Pfizer Investigational Site | Raleigh | North Carolina | United States | 27603 |
32 | Pfizer Investigational Site | Cincinnati | Ohio | United States | 45220 |
33 | Pfizer Investigational Site | Cincinnati | Ohio | United States | 45267-0559 |
34 | Pfizer Investigational Site | Oklahoma City | Oklahoma | United States | 73118 |
35 | Pfizer Investigational Site | Bellaire | Texas | United States | 77401 |
36 | Pfizer Investigational Site | Dallas | Texas | United States | 75228 |
37 | Pfizer Investigational Site | Houston | Texas | United States | 77008 |
38 | Pfizer Investigational Site | Irving | Texas | United States | 75062 |
39 | Pfizer Investigational Site | Arlington | Virginia | United States | 22204 |
40 | Pfizer Investigational Site | Arlington | Virginia | United States | 22205 |
41 | Pfizer Investigational Site | Falls Church | Virginia | United States | 22041 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A1281110