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

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

The purpose of this study is to compare the efficacy and safety of ziprasidone and aripiprazole in hospitalized patients with schizophrenia or schizoaffective disorder

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Aripiprazole; Drug: Ziprasidone

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92804
      • Pfizer Investigational Site
    • Cerritos, California, United States, 90703
      • Pfizer Investigational Site
    • Culver City, California, United States, 90232
      • Pfizer Investigational Site
    • Garden Grove, California, United States, 92845
      • Pfizer Investigational Site
    • Glendale, California, United States, 91206
      • Pfizer Investigational Site
    • La Mesa, California, United States, 91942
      • Pfizer Investigational Site
    • Newport Beach, California, United States, 92663
      • Pfizer Investigational Site
    • Paramount, California, United States, 90723
      • Pfizer Investigational Site
    • Riverside, California, United States, 92506
      • Pfizer Investigational Site
    • San Diego, California, United States, 92105
      • Pfizer Investigational Site
    • San Diego, California, United States, 92123
      • Pfizer Investigational Site
    • San Diego, California, United States, 92126
      • Pfizer Investigational Site
    • Torrance, California, United States, 90505
      • Pfizer Investigational Site
    • Upland, California, United States, 91786
      • Pfizer Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Pfizer Investigational Site
  • Florida
    • Hialeah, Florida, United States, 33016
      • Pfizer Investigational Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Pfizer Investigational Site
    • Rockville, Maryland, United States, 20850
      • Pfizer Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63118
      • Pfizer Investigational Site
    • Saint Louis, Missouri, United States, 63104
      • Pfizer Investigational Site
  • New Jersey
    • Clementon, New Jersey, United States, 08021
      • Pfizer Investigational Site
    • Princeton, New Jersey, United States, 08540
      • Pfizer Investigational Site
    • Westampton, New Jersey, United States, 08060
      • Pfizer Investigational Site
    • Willingboro, New Jersey, United States, 08046
      • Pfizer Investigational Site
  • New York
    • Jamaica, New York, United States, 11418
      • Pfizer Investigational Site
    • Staten Island, New York, United States, 10305
      • Pfizer Investigational Site
  • North Carolina
    • Butner, North Carolina, United States, 27509
      • Pfizer Investigational Site
    • Chapel Hill, North Carolina, United States, 27599-7160
      • Pfizer Investigational Site
    • Durham, North Carolina, United States, 27705
      • Pfizer Investigational Site
    • Raleigh, North Carolina, United States, 27603
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0559
      • Pfizer Investigational Site
    • Cincinnati, Ohio, United States, 45220
      • Pfizer Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Pfizer Investigational Site
  • Texas
    • Bellaire, Texas, United States, 77401
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75228
      • Pfizer Investigational Site
    • Houston, Texas, United States, 77008
      • Pfizer Investigational Site
    • Irving, Texas, United States, 75062
      • Pfizer Investigational Site
  • Virginia
    • Arlington, Virginia, United States, 22205
      • Pfizer Investigational Site
    • Arlington, Virginia, United States, 22204
      • Pfizer Investigational Site
    • Falls Church, Virginia, United States, 22041
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Aripiprazole	Drug: Aripiprazole; 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
ACTIVE_COMPARATOR: Ziprasidone	Drug: Ziprasidone; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores.	28 days
Change from baseline to endpoint in Brief Psychiatric Rating Scale derived (BPRSd) total scores.	28 days

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Study Completion (ACTUAL): March 1, 2005

Study Registration Dates

• First Submitted: March 5, 2008
• First Submitted That Met QC Criteria: March 5, 2008
• First Posted (ESTIMATE): March 13, 2008

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole; Ziprasidone
• Other Study ID Numbers: A1281110