Clinical trial NCT00406315: Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone
Official title: A Sixteen-Week, Multi-Center, Open-Label Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone In Subjects Diagnosed With Schizophrenia Or Schizoaffective Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: ziprasidone, quetiapine (Seroquel) switch, open label, flexible dose, schizophrenia, schizoaffective disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate change in weight as a result of switching from quetiapine to ziprasidone, in subjects with schizophrenia or schizoaffective disorder who have failed to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability.


Eligibility criteria: Inclusion Criteria:

* Males or females, between 18 and 55 years of age, at the time of consent.
* Subjects must have a primary diagnosis of schizophrenia, any subtype (code 295.xx), or schizoaffective disorder as defined in DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition)
* Subjects must have normal vital signs, physical examination, ECG, and laboratory findings except for minor deviations determined and documented to be clinically insignificant by the investigator or a sub-investigator who is a medical doctor.

Exclusion Criteria:

* Subjects who are unable to provide informed consent
* Subjects who meet criteria for a DSM-IV-TR Axis I (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition) diagnosis other than schizophrenia or schizoaffective disorder, including psychoactive substance abuse or dependence within one year of study entry
* Females who are pregnant, breast feeding, or lactating at screening.

Primary outcomes:
measure: Change From Baseline in Weight at Week 16
timeFrame: Baseline, Week 16, Week 16 LOCF
Secondary outcomes:
measure: Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Fasting Glucose at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Fasting Insulin at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Waist and Hip Circumference at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16
timeFrame: Baseline, Week 16, Week 16 LOCF
measure: Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16
timeFrame: Baseline, Week 16, Week 16 LOCF
measure: Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16
timeFrame: Week 16, Week 16 LOCF
measure: Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16
timeFrame: Baseline, Week 16, Week 16 LOCF
measure: Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16
timeFrame: Baseline, Week 16, Week 16 LOCF
measure: Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16
timeFrame: Baseline, Week 16, Week 16 LOCF
measure: Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16
timeFrame: Baseline, Week 16, Week 16 LOCF
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Costa Mesa
country: United States
facility: Pfizer Investigational Site
state: California
city: Garden Grove
country: United States
facility: Pfizer Investigational Site
state: California
city: National City
country: United States
facility: Pfizer Investigational Site
state: California
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Temecula
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Hialeah
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Des Plaines
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Schaumburg
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Topeka
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Olive Branch
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Nashua
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Olean
country: United States
facility: Pfizer Investigational Site
state: New York
city: Staten Island
country: United States
facility: Pfizer Investigational Site
state: New York
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: DeSoto
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Bothell
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Kirkland
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Aparecida de Goiânia
country: Brazil
facility: Pfizer Investigational Site
state: GO
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Duesseldorf
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Zamora
country: Spain
facility: Pfizer Investigational Site
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Izmit
country: Turkey
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: