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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00634348
First received: March 5, 2008
Last updated: June 17, 2008
Last verified: June 2008
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: Aripiprazole
Drug: Ziprasidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in Brief Psychiatric Rating Scale derived (BPRSd) total scores. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS negative subscale scores. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS Depression factor scores. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in Calgary Depression Scale for Schizophrenia (CDSS) scores. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change from baseline to Days 2, 4, 7, 14, 21, and 28 in COVI Anxiety Scale scores. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in Global Assessment of Functioning (GAF) scale scores. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in Personal Evaluation of Transition in Treatment (PETiT) scale scores. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in Patient Preference Scale (PPS) scores. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in Life Skills Profile (LSP). [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change from baseline in Outcome Resource Discharge Questionnaire (ORDQ) scores on Days 2, 4, 7, 14, 21, and 28. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in Cognitive Battery. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS total scores. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Adverse events, laboratory evaluations, vital signs, electrocardiograms at baseline and on Days 2, 4, 7, 14, 21, and 28. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Change from baseline to Day 28 in movement disorder rating scale scores. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 256
Study Start Date: April 2004
Study Completion Date: March 2005
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634348

  Show 41 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00634348     History of Changes
Other Study ID Numbers: A1281110
Study First Received: March 5, 2008
Last Updated: June 17, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Ziprasidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 24, 2014