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

NCT00406315 | Completed Phase 4 Results

• 1 other identifier: A1281148
• Study Type: interventional
• Target: 255
• Locations: 6 countries
• Sites: 40

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

ziprasidone, quetiapine (Seroquel) switch, open label, flexible dose, schizophrenia, schizoaffective disorder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Weight at Week 16

  Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline.

  Baseline, Week 16, Week 16 LOCF

Secondary Outcomes (14)

• Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16

  Baseline, Week 16

• Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16

  Baseline, Week 16

• Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16

  Baseline, Week 16

• Change From Baseline in Fasting Glucose at Week 16

  Baseline, Week 16

• Change From Baseline in Fasting Insulin at Week 16

  Baseline, Week 16

Study Arms (1)

A1

OTHER

atypical antipsychotic for the treatment of schizophrenia

Drug: ziprasidone

Interventions

ziprasidone DRUG

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

Also known as: Geodon, Zeldox

A1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (40)

Pfizer Investigational Site

Phoenix, Arizona, 85028, United States

Location

Pfizer Investigational Site

Costa Mesa, California, 92626, United States

Location

Pfizer Investigational Site

Garden Grove, California, 92845, United States

Location

Pfizer Investigational Site

National City, California, 91950, United States

Location

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Orange, California, 92868-8040, United States

Location

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San Diego, California, 92123, United States

Location

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Temecula, California, 92591, United States

Location

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Torrance, California, 90505, United States

Location

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Hialeah, Florida, 33016, United States

Location

Pfizer Investigational Site

Miami, Florida, 33126, United States

Location

Pfizer Investigational Site

Miami, Florida, 33143, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60640, United States

Location

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Des Plaines, Illinois, 60016, United States

Location

Pfizer Investigational Site

Oakbrook Terrace, Illinois, 60181, United States

Location

Pfizer Investigational Site

Schaumburg, Illinois, 60194, United States

Location

Pfizer Investigational Site

Topeka, Kansas, 66606, United States

Location

Pfizer Investigational Site

Olive Branch, Mississippi, 38654, United States

Location

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St Louis, Missouri, 63368, United States

Location

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Las Vegas, Nevada, 89102, United States

Location

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Nashua, New Hampshire, 03060, United States

Location

Pfizer Investigational Site

Olean, New York, 14760, United States

Location

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Staten Island, New York, 10312, United States

Location

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Memphis, Tennessee, 38117, United States

Location

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Memphis, Tennessee, 38133, United States

Location

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Dallas, Texas, 75231, United States

Location

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DeSoto, Texas, 75115, United States

Location

Pfizer Investigational Site

Bothell, Washington, 98011, United States

Location

Pfizer Investigational Site

Kirkland, Washington, 98033, United States

Location

Pfizer Investigational Site

Aparecida de Goiânia, Goiás, 74922-810, Brazil

Location

Pfizer Investigational Site

Rio de Janeiro, Rio de Janeiro, 22290-140, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 05403-010, Brazil

Location

Pfizer Investigational Site

Berlin, 10117, Germany

Location

Pfizer Investigational Site

Düsseldorf, 40629, Germany

Location

Pfizer Investigational Site

Hamburg, 20246, Germany

Location

Pfizer Investigational Site

München, 80336, Germany

Location

Pfizer Investigational Site

Athens, 10676, Greece

Location

Pfizer Investigational Site

Thessaloniki, 546 42, Greece

Location

Pfizer Investigational Site

Zamora, 49021, Spain

Location

Pfizer Investigational Site

Ankara, 06200, Turkey (Türkiye)

Location

Pfizer Investigational Site

İzmit, 41380, Turkey (Türkiye)

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2006
• First Posted: December 4, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: March 1, 2009
• Last Updated: March 29, 2021
• Results First Posted: February 2, 2010

Record last verified: 2021-03

Locations

ES (1); TU (2); BR (3); DE (4); US (28); GR (2)