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

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
ziprasidone
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring ziprasidone, quetiapine (Seroquel) switch, open label, flexible dose, schizophrenia, schizoaffective disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

A1

Arm Description

atypical antipsychotic for the treatment of schizophrenia

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16
Total cholesterol value: Change = value at Week 16 minus value at Baseline.
Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16
HDL, LDL, and triglyceride value: Change = value at Week 16 minus value at Baseline.
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16
HbAlc value: Change = value at Week 16 minus value at Baseline.
Change From Baseline in Fasting Glucose at Week 16
Fasting glucose value: Change = value at Week 16 minus value at Baseline.
Change From Baseline in Fasting Insulin at Week 16
Fasting insulin value: Change = value at Week 16 minus value at Baseline.
Change From Baseline in Waist and Hip Circumference at Week 16
Waist and hip circumference value: Change = value at Week 16 minus value at Baseline.
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16
AIMS: a 12-item clinician administered instrument assessing observed abnormal movements in different parts of body. Ten items scored on a 5-point scale (0 = none/normal, 4 = severe) evaluate abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42. Item 8 indicates severity, item 9 indicates Incapacitation. AIMS total, global severity, or global incapacitation score: Change = score at Week 16 minus score at Baseline.
Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16
PANSS measures severity of psychopathology in subjects with schizophrenia, schizoaffective disorder and other psychotic disorders. It includes 3 scales and a total of 30 items: 7 items comprise the positive scale, 7 comprise the negative scale, and 16 items measure general psychopathology. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. PANSS total score and positive and negative scores: Change = score at Week 16 or Week 16 LOCF minus score at Baseline.
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16
The CGI-S is a single item, clinician-rated scale that assesses the global severity of the subject's overall illness. The CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). CGI-S score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16
The CGI-I is a 7-point, single-item, clinician-rated scale that assesses global improvement in the subject's clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse).
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16
The CDSS is a 9-item, clinician-rated scale validated for rating the severity of depressive symptoms in subjects diagnosed with schizophrenia, and independent of confounding negative and extrapyramidal symptoms. The CDSS rates the severity of depressive symptoms on a 4-point scale ranging from 0 (absent) to 3 (severe). The CDSS depression total score is obtained by adding each of the item scores. Total possible score ranges from 0 to 27. CDSS possible total score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16
The SCoRS is a 20-question rating scale completed via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. Each question was completed using a 4-point scale (ranging from 1=none to 4=severe). Total possible score ranged from 20 to 80. At the end of the 20 questions, the interviewer completed a Global Scale of 1-10, rating subject's overall difficulty. Higher scores on both indicated greater cognitive impairment. SCoRS total score and global rating: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16
GAF Scale measures the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale. Total possible score ranges from 0 (not enough information available to provide GAF) to 100 (Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many qualities. No symptoms). The assessment was done by a trained assessor. GAF scale score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16
The TSQM is a 13-item subject-rated scale that evaluates the effectiveness, side effects and convenience of the medication over the past 2-3 weeks. Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100. TSQM Effectivenss, Side Effect, Convenience, and Global Satisfaction scores: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.

Full Information

First Posted
November 29, 2006
Last Updated
March 1, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00406315
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
ziprasidone, quetiapine (Seroquel) switch, open label, flexible dose, schizophrenia, schizoaffective disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Other
Arm Description
atypical antipsychotic for the treatment of schizophrenia
Intervention Type
Drug
Intervention Name(s)
ziprasidone
Other Intervention Name(s)
Geodon, Zeldox
Intervention Description
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
Primary Outcome Measure Information:
Title
Change From Baseline in Weight at Week 16
Description
Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline.
Time Frame
Baseline, Week 16, Week 16 LOCF
Secondary Outcome Measure Information:
Title
Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16
Description
Total cholesterol value: Change = value at Week 16 minus value at Baseline.
Time Frame
Baseline, Week 16
Title
Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16
Description
HDL, LDL, and triglyceride value: Change = value at Week 16 minus value at Baseline.
Time Frame
Baseline, Week 16
Title
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16
Description
HbAlc value: Change = value at Week 16 minus value at Baseline.
Time Frame
Baseline, Week 16
Title
Change From Baseline in Fasting Glucose at Week 16
Description
Fasting glucose value: Change = value at Week 16 minus value at Baseline.
Time Frame
Baseline, Week 16
Title
Change From Baseline in Fasting Insulin at Week 16
Description
Fasting insulin value: Change = value at Week 16 minus value at Baseline.
Time Frame
Baseline, Week 16
Title
Change From Baseline in Waist and Hip Circumference at Week 16
Description
Waist and hip circumference value: Change = value at Week 16 minus value at Baseline.
Time Frame
Baseline, Week 16
Title
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16
Description
AIMS: a 12-item clinician administered instrument assessing observed abnormal movements in different parts of body. Ten items scored on a 5-point scale (0 = none/normal, 4 = severe) evaluate abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42. Item 8 indicates severity, item 9 indicates Incapacitation. AIMS total, global severity, or global incapacitation score: Change = score at Week 16 minus score at Baseline.
Time Frame
Baseline, Week 16
Title
Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16
Description
PANSS measures severity of psychopathology in subjects with schizophrenia, schizoaffective disorder and other psychotic disorders. It includes 3 scales and a total of 30 items: 7 items comprise the positive scale, 7 comprise the negative scale, and 16 items measure general psychopathology. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. PANSS total score and positive and negative scores: Change = score at Week 16 or Week 16 LOCF minus score at Baseline.
Time Frame
Baseline, Week 16, Week 16 LOCF
Title
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16
Description
The CGI-S is a single item, clinician-rated scale that assesses the global severity of the subject's overall illness. The CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). CGI-S score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time Frame
Baseline, Week 16, Week 16 LOCF
Title
Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16
Description
The CGI-I is a 7-point, single-item, clinician-rated scale that assesses global improvement in the subject's clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse).
Time Frame
Week 16, Week 16 LOCF
Title
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16
Description
The CDSS is a 9-item, clinician-rated scale validated for rating the severity of depressive symptoms in subjects diagnosed with schizophrenia, and independent of confounding negative and extrapyramidal symptoms. The CDSS rates the severity of depressive symptoms on a 4-point scale ranging from 0 (absent) to 3 (severe). The CDSS depression total score is obtained by adding each of the item scores. Total possible score ranges from 0 to 27. CDSS possible total score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time Frame
Baseline, Week 16, Week 16 LOCF
Title
Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16
Description
The SCoRS is a 20-question rating scale completed via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. Each question was completed using a 4-point scale (ranging from 1=none to 4=severe). Total possible score ranged from 20 to 80. At the end of the 20 questions, the interviewer completed a Global Scale of 1-10, rating subject's overall difficulty. Higher scores on both indicated greater cognitive impairment. SCoRS total score and global rating: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time Frame
Baseline, Week 16, Week 16 LOCF
Title
Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16
Description
GAF Scale measures the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale. Total possible score ranges from 0 (not enough information available to provide GAF) to 100 (Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many qualities. No symptoms). The assessment was done by a trained assessor. GAF scale score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time Frame
Baseline, Week 16, Week 16 LOCF
Title
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16
Description
The TSQM is a 13-item subject-rated scale that evaluates the effectiveness, side effects and convenience of the medication over the past 2-3 weeks. Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100. TSQM Effectivenss, Side Effect, Convenience, and Global Satisfaction scores: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time Frame
Baseline, Week 16, Week 16 LOCF

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Facility Name
Pfizer Investigational Site
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Pfizer Investigational Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Pfizer Investigational Site
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Pfizer Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868-8040
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Pfizer Investigational Site
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Pfizer Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Pfizer Investigational Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Pfizer Investigational Site
City
Des Plaines
State/Province
Illinois
ZIP/Postal Code
60016
Country
United States
Facility Name
Pfizer Investigational Site
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Facility Name
Pfizer Investigational Site
City
Schaumburg
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
Facility Name
Pfizer Investigational Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Pfizer Investigational Site
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
Pfizer Investigational Site
City
Olean
State/Province
New York
ZIP/Postal Code
14760
Country
United States
Facility Name
Pfizer Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38117
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38133
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pfizer Investigational Site
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Pfizer Investigational Site
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States
Facility Name
Pfizer Investigational Site
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
Pfizer Investigational Site
City
Aparecida de Goiânia
State/Province
GO
ZIP/Postal Code
74922-810
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22290-140
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Pfizer Investigational Site
City
Duesseldorf
ZIP/Postal Code
40629
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Pfizer Investigational Site
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Pfizer Investigational Site
City
Thessaloniki
ZIP/Postal Code
546 42
Country
Greece
Facility Name
Pfizer Investigational Site
City
Zamora
ZIP/Postal Code
49021
Country
Spain
Facility Name
Pfizer Investigational Site
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Izmit
ZIP/Postal Code
41380
Country
Turkey

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281148&StudyName=Study%20Evaluating%20The%20Safety%2C%20Tolerability%2C%20And%20Efficacy%20Of%20Switching%20From%20Quetiapine%20To%20Ziprasidone
Description
To obtain contact information for a study center near you, click here.

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

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