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A Study Comparing the Efficacy and Safety of Ziprasidone and Aripiprazole for the Treatment fo Schizophrenia or Schizoaffective Disorder in Hospitalized Patients

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hospitalized patients with schizophrenia or schizoaffective disorder
  • At least a 6th grade reading level
  • Males or females, between 18 and 70 years of age at the time of consent
  • Subjects must have been hospitalized for no more than 14 consecutive days immediately prior to screening

Exclusion Criteria:

  • Psychiatric disorder other than schizophrenia or schizoaffective disorder
  • History of arrhythmia, heart attack, or heart failure

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
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Aripiprazole

Ziprasidone

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores.
Change from baseline to endpoint in Brief Psychiatric Rating Scale derived (BPRSd) total scores.

Secondary Outcome Measures

Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Positive and Negative Syndrome Scale (PANSS) positive subscale scores.
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS negative subscale scores.
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS Depression factor scores.
Change from baseline to endpoint in Calgary Depression Scale for Schizophrenia (CDSS) scores.
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in COVI Anxiety Scale scores.
Change from baseline to endpoint in Global Assessment of Functioning (GAF) scale scores.
Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores.
Change from baseline to endpoint in Personal Evaluation of Transition in Treatment (PETiT) scale scores.
Change from baseline to endpoint in Patient Preference Scale (PPS) scores.
Change from baseline to endpoint in Life Skills Profile (LSP).
Change from baseline in Outcome Resource Discharge Questionnaire (ORDQ) scores on Days 2, 4, 7, 14, 21, and 28.
Change from baseline to endpoint in Cognitive Battery.
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS total scores.
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Clinical Global Impressions-Improvement (CGI-I) scale scores.
Adverse events, laboratory evaluations, vital signs, electrocardiograms at baseline and on Days 2, 4, 7, 14, 21, and 28.
Change from baseline to Day 28 in movement disorder rating scale scores.

Full Information

First Posted
March 5, 2008
Last Updated
February 18, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00634348
Brief Title
A Study Comparing the Efficacy and Safety of Ziprasidone and Aripiprazole for the Treatment fo Schizophrenia or Schizoaffective Disorder in Hospitalized Patients
Official Title
A Four-Week Double Blind Multicenter Study Comparing The Efficacy And Safety Of Ziprasidone To Aripiprazole In Subjects With Schizophrenia Or Schizoaffective Disorder Needing Inpatient Care
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (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 purpose of this study is to compare the efficacy and safety of ziprasidone and aripiprazole in hospitalized patients with schizophrenia or schizoaffective disorder

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aripiprazole
Arm Type
Active Comparator
Arm Title
Ziprasidone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
Oral aripiprazole capsules 15 mg once daily from Days 1-14; thereafter, doses could be adjusted on Days 14 and 21 to 10, 15, or 30 mg once daily; patients treated for 28 days
Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Intervention Description
Oral ziprasidone capsules 40 mg twice daily on Day 1, 60 mg twice daily on Day 2, 80 mg twice daily on Days 3-14; thereafter, doses could be adjusted on Days 14 and 21 to 40, 60, or 80 mg twice daily; patients treated for 28 days
Primary Outcome Measure Information:
Title
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores.
Time Frame
28 days
Title
Change from baseline to endpoint in Brief Psychiatric Rating Scale derived (BPRSd) total scores.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Positive and Negative Syndrome Scale (PANSS) positive subscale scores.
Time Frame
28 days
Title
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS negative subscale scores.
Time Frame
28 days
Title
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS Depression factor scores.
Time Frame
28 days
Title
Change from baseline to endpoint in Calgary Depression Scale for Schizophrenia (CDSS) scores.
Time Frame
28 days
Title
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in COVI Anxiety Scale scores.
Time Frame
28 days
Title
Change from baseline to endpoint in Global Assessment of Functioning (GAF) scale scores.
Time Frame
28 days
Title
Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores.
Time Frame
28 days
Title
Change from baseline to endpoint in Personal Evaluation of Transition in Treatment (PETiT) scale scores.
Time Frame
28 days
Title
Change from baseline to endpoint in Patient Preference Scale (PPS) scores.
Time Frame
28 days
Title
Change from baseline to endpoint in Life Skills Profile (LSP).
Time Frame
28 days
Title
Change from baseline in Outcome Resource Discharge Questionnaire (ORDQ) scores on Days 2, 4, 7, 14, 21, and 28.
Time Frame
28 days
Title
Change from baseline to endpoint in Cognitive Battery.
Time Frame
28 days
Title
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS total scores.
Time Frame
28 days
Title
Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Clinical Global Impressions-Improvement (CGI-I) scale scores.
Time Frame
28 days
Title
Adverse events, laboratory evaluations, vital signs, electrocardiograms at baseline and on Days 2, 4, 7, 14, 21, and 28.
Time Frame
28 days
Title
Change from baseline to Day 28 in movement disorder rating scale scores.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalized patients with schizophrenia or schizoaffective disorder At least a 6th grade reading level Males or females, between 18 and 70 years of age at the time of consent Subjects must have been hospitalized for no more than 14 consecutive days immediately prior to screening Exclusion Criteria: Psychiatric disorder other than schizophrenia or schizoaffective disorder History of arrhythmia, heart attack, or heart failure
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
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Pfizer Investigational Site
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Pfizer Investigational Site
City
Culver City
State/Province
California
ZIP/Postal Code
90232
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
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Pfizer Investigational Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Pfizer Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Pfizer Investigational Site
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Pfizer Investigational Site
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92105
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
San Diego
State/Province
California
ZIP/Postal Code
92126
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
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Pfizer Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
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
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Pfizer Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
Pfizer Investigational Site
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
Pfizer Investigational Site
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Pfizer Investigational Site
City
Westampton
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Pfizer Investigational Site
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Pfizer Investigational Site
City
Jamaica
State/Province
New York
ZIP/Postal Code
11418
Country
United States
Facility Name
Pfizer Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Pfizer Investigational Site
City
Butner
State/Province
North Carolina
ZIP/Postal Code
27509
Country
United States
Facility Name
Pfizer Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7160
Country
United States
Facility Name
Pfizer Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Pfizer Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0559
Country
United States
Facility Name
Pfizer Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Pfizer Investigational Site
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75228
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Pfizer Investigational Site
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
Pfizer Investigational Site
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22204
Country
United States
Facility Name
Pfizer Investigational Site
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Pfizer Investigational Site
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22041
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study Comparing the Efficacy and Safety of Ziprasidone and Aripiprazole for the Treatment fo Schizophrenia or Schizoaffective Disorder in Hospitalized Patients

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