Clinical trial NCT00645515: A Study Comparing the Safety and Efficacy of Ziprasidone and Risperidone for the Treatment of Chronic Schizophrenia
Official title: Ziprasidone Versus Risperidone In The Treatment Of Chronic Schizophrenia: A Six Months, Double Blind Randomized, Parallel Group Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety of ziprasidone and risperidone for the treatment of chronic schizophrenia. The primary purpose is to differentiate the effects of ziprasidone and risperidone on extrapyramidal side effects and the secondary purpose is to compare their tolerability and efficacy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia
* CGI-S score of 4 or less at baseline

Exclusion Criteria:

* Concurrent antipsychotic treatment
* Treatment with antidepressants or mood stabilizers within 2 weeks of randomization
* Acute exacerbation of schizophrenia within 3 months of baseline

Primary outcomes:
measure: Change from baseline in Simpson-Angus Scale (SAS) scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
timeFrame: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Secondary outcomes:
measure: Change from baseline in cognitive function assessment at Weeks 4 and 24
timeFrame: Day 1 and Weeks 4 and 24
measure: Change from baseline in Patient Preference Scale (PPS) at Weeks 4, 10, 12, 16, and 24
timeFrame: Day 1 and Weeks 4, 10, 12, 16, and 24
measure: Changes in Sexual Functioning Questionnaire at Weeks 1, 4, 12, 16, and 24
timeFrame: Day 1 and Weeks 1, 4, 12, 16, and 24
measure: Change from baseline in Cuestionario Sevilla at Weeks 1, 4, 12, 16, and 24
timeFrame: Day 1 and Weeks 1, 4, 12, 16, and 24
measure: Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores at Weeks 3, 4, 6, 10, 12, 16, and 24
timeFrame: Day 1 and Weeks 3, 4, 6, 10, 12, 16, and 24
measure: Laboratory tests and electrocardiogram at Week 24
timeFrame: Screening and Week 24
measure: Adverse events on Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
timeFrame: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
measure: Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
timeFrame: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
measure: Clinical Global Impressions-Improvement (CGI-I) scale scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
timeFrame: Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
measure: Change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores and negative subscale scores at Weeks 4, 10, 12, 16, and 24
timeFrame: Day 1 and Weeks 4, 10, 12, 16, and 24
measure: Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movements Scale (AIMS) scores at Weeks 4, 10, 12, 16, and 24
timeFrame: Day 1 and Weeks 4, 10, 12, 16, and 24
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Pfizer Investigational Site
state: Vizcaya
city: Getxo
country: Spain
facility: Pfizer Investigational Site
state: Vizcaya
city: Madrid
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: