Clinical trial NCT00634348: A Study Comparing the Efficacy and Safety of Ziprasidone and Aripiprazole for the Treatment fo Schizophrenia or Schizoaffective Disorder in Hospitalized Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-13
Enrollment: 256
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 efficacy and safety of ziprasidone and aripiprazole in hospitalized patients with schizophrenia or schizoaffective disorder


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores.
timeFrame: 28 days
measure: Change from baseline to endpoint in Brief Psychiatric Rating Scale derived (BPRSd) total scores.
timeFrame: 28 days
Secondary outcomes:
measure: Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Positive and Negative Syndrome Scale (PANSS) positive subscale scores.
timeFrame: 28 days
measure: Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS negative subscale scores.
timeFrame: 28 days
measure: Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS Depression factor scores.
timeFrame: 28 days
measure: Change from baseline to endpoint in Calgary Depression Scale for Schizophrenia (CDSS) scores.
timeFrame: 28 days
measure: Change from baseline to Days 2, 4, 7, 14, 21, and 28 in COVI Anxiety Scale scores.
timeFrame: 28 days
measure: Change from baseline to endpoint in Global Assessment of Functioning (GAF) scale scores.
timeFrame: 28 days
measure: Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores.
timeFrame: 28 days
measure: Change from baseline to endpoint in Personal Evaluation of Transition in Treatment (PETiT) scale scores.
timeFrame: 28 days
measure: Change from baseline to endpoint in Patient Preference Scale (PPS) scores.
timeFrame: 28 days
measure: Change from baseline to endpoint in Life Skills Profile (LSP).
timeFrame: 28 days
measure: Change from baseline in Outcome Resource Discharge Questionnaire (ORDQ) scores on Days 2, 4, 7, 14, 21, and 28.
timeFrame: 28 days
measure: Change from baseline to endpoint in Cognitive Battery.
timeFrame: 28 days
measure: Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS total scores.
timeFrame: 28 days
measure: Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Clinical Global Impressions-Improvement (CGI-I) scale scores.
timeFrame: 28 days
measure: Adverse events, laboratory evaluations, vital signs, electrocardiograms at baseline and on Days 2, 4, 7, 14, 21, and 28.
timeFrame: 28 days
measure: Change from baseline to Day 28 in movement disorder rating scale scores.
timeFrame: 28 days
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Cerritos
country: United States
facility: Pfizer Investigational Site
state: California
city: Culver City
country: United States
facility: Pfizer Investigational Site
state: California
city: Garden Grove
country: United States
facility: Pfizer Investigational Site
state: California
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
city: La Mesa
country: United States
facility: Pfizer Investigational Site
state: California
city: Newport Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Paramount
country: United States
facility: Pfizer Investigational Site
state: California
city: Riverside
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Upland
country: United States
facility: Pfizer Investigational Site
state: California
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Hialeah
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Rockville
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Clementon
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Princeton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Westampton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Willingboro
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Jamaica
country: United States
facility: Pfizer Investigational Site
state: New York
city: Staten Island
country: United States
facility: Pfizer Investigational Site
state: New York
city: Butner
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Chapel Hill
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Bellaire
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Irving
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Falls Church
country: United States
facility: Pfizer Investigational Site
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: