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Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone

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NCT00406315

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85028 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia, Schizoaffective Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00406315
Pfizer
Completed
Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone

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Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone
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
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
Drug: ziprasidone
Days 1-3: 40 mg twice a day (BID); Days 4-7: 60 mg BID; Day 8: 80 mg BID; Flexible dose between 40-80 mg BID (adjustable up to 40 mg daily/week) for the remainder of the 16-week treatment phase and continuing throughout the 16-week follow-up phase
Other Name: Geodon, Zeldox
A1
atypical antipsychotic for the treatment of schizophrenia
Intervention: Drug: ziprasidone
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
March 2009
December 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Germany,   Greece,   Spain,   Turkey,   United States
 
 
NCT00406315
A1281148
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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