Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00406315

Purpose

The primary objective of this study is to evaluate change in weight as a result of switching to ziprasidone, in schizophrenic subjects who have failed to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability.

Condition	Intervention	Phase
Schizophrenia or Schizoaffective Disorder	Drug: ziprasidone	Phase IV

MedlinePlus related topics: Schizophrenia

Drug Information available for: Quetiapine Quetiapine fumarate Ziprasidone Ziprasidone hydrochloride Ziprasidone mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change in weight (kg) between Baseline and Week 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Spontaneously reported adverse events during the study [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Waist and hip circumference [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Subjects reporting any adverse event during the study [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Subjects reporting a mild, moderate, or severe adverse event during the study [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Subjects discontinuing due to an adverse event during the study [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Subjects who develop clinically significant abnormalities in blood chemistries, hematologies, or ECG parameters during the study [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Treatment Satisfaction Questionnaire for Medication (TQSM) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Positive and Negative Symptoms of Schizophrenia (PANSS) total score and positive and negative subscale scores [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression, Improvement Scale (CGI-I) change from Clinical Global Impression, Severity Scale (CGI-S) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Schizophrenia Cognition Rating Scale (SCoRS) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Global Assessment of Function Scale (GAF) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Laboratory measures, specifically: fasting lipid profile (total cholesterol), HDL, LDL, and triglycerides, HbA1c, and fasting glucose and insulin [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	250
Study Start Date:	November 2006
Estimated Study Completion Date:	March 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1 atypical antipsychotic for the treatment of schizophrenia	Drug: ziprasidone Days 1-3: 40 mg 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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406315

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 41 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1281148
Study First Received:	November 29, 2006
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00406315
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

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

Study placed in the following topic categories:

Schizophrenia
Quetiapine
Dopamine
Mental Disorders

Psychotic Disorders
Ziprasidone
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009