Aripiprazole
DrugOral 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
Completed
NCT Number: NCT00634348
A Study Comparing the Efficacy and Safety of Ziprasidone and Aripiprazole for the Treatment fo Schizophrenia or Schizoaffective Disorder in Hospitalized Patients
The purpose of this study is to compare the efficacy and safety of ziprasidone and aripiprazole in hospitalized patients with schizophrenia or schizoaffective disorder
Completed
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Notify MeKey information
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Pfizer Investigational Site, Anaheim, California, United States
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Hospitalized patients with schizophrenia or schizoaffective disorder
- At least a 6th grade reading level
- Males or females, between 18 and 70 years of age at the time of consent
- Subjects must have been hospitalized for no more than 14 consecutive days immediately prior to screening
Exclusion criteria
- Psychiatric disorder other than schizophrenia or schizoaffective disorder
- History of arrhythmia, heart attack, or heart failure
Treatment and study plan
Ziprasidone
DrugOral 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
Primary outcomes
-
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores.
Time frame: 28 days
-
Change from baseline to endpoint in Brief Psychiatric Rating Scale derived (BPRSd) total scores.
Time frame: 28 days
Secondary outcomes
-
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Positive and Negative Syndrome Scale (PANSS) positive subscale scores.
Time frame: 28 days
-
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS negative subscale scores.
Time frame: 28 days
-
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS Depression factor scores.
Time frame: 28 days
-
Change from baseline to endpoint in Calgary Depression Scale for Schizophrenia (CDSS) scores.
Time frame: 28 days
-
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in COVI Anxiety Scale scores.
Time frame: 28 days
-
Change from baseline to endpoint in Global Assessment of Functioning (GAF) scale scores.
Time frame: 28 days
-
Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores.
Time frame: 28 days
-
Change from baseline to endpoint in Personal Evaluation of Transition in Treatment (PETiT) scale scores.
Time frame: 28 days
-
Change from baseline to endpoint in Patient Preference Scale (PPS) scores.
Time frame: 28 days
-
Change from baseline to endpoint in Life Skills Profile (LSP).
Time frame: 28 days
-
Change from baseline in Outcome Resource Discharge Questionnaire (ORDQ) scores on Days 2, 4, 7, 14, 21, and 28.
Time frame: 28 days
-
Change from baseline to endpoint in Cognitive Battery.
Time frame: 28 days
-
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS total scores.
Time frame: 28 days
-
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Clinical Global Impressions-Improvement (CGI-I) scale scores.
Time frame: 28 days
-
Adverse events, laboratory evaluations, vital signs, electrocardiograms at baseline and on Days 2, 4, 7, 14, 21, and 28.
Time frame: 28 days
-
Change from baseline to Day 28 in movement disorder rating scale scores.
Time frame: 28 days
Sponsors and collaborators
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Industry
Registry information
Official study title
A Four-Week Double Blind Multicenter Study Comparing The Efficacy And Safety Of Ziprasidone To Aripiprazole In Subjects With Schizophrenia Or Schizoaffective Disorder Needing Inpatient Care
Important dates
- Study start
- 2004
- Study completion
- 2005
- First posted
- Mar 13, 2008
- Registry last updated
- Feb 21, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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