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Trial record 1 of 1 for:    NCT00634348
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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

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ClinicalTrials.gov Identifier: NCT00634348
Recruitment Status : Completed
First Posted : March 13, 2008
Last Update Posted : March 10, 2017
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 5, 2008
First Posted Date  ICMJE March 13, 2008
Last Update Posted Date March 10, 2017
Study Start Date  ICMJE April 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2008)
  • Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores. [ Time Frame: 28 days ]
  • Change from baseline to endpoint in Brief Psychiatric Rating Scale derived (BPRSd) total scores. [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00634348 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2008)
  • 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 ]
  • Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS negative subscale scores. [ Time Frame: 28 days ]
  • Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS Depression factor scores. [ Time Frame: 28 days ]
  • Change from baseline to endpoint in Calgary Depression Scale for Schizophrenia (CDSS) scores. [ Time Frame: 28 days ]
  • Change from baseline to Days 2, 4, 7, 14, 21, and 28 in COVI Anxiety Scale scores. [ Time Frame: 28 days ]
  • Change from baseline to endpoint in Global Assessment of Functioning (GAF) scale scores. [ Time Frame: 28 days ]
  • Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores. [ Time Frame: 28 days ]
  • Change from baseline to endpoint in Personal Evaluation of Transition in Treatment (PETiT) scale scores. [ Time Frame: 28 days ]
  • Change from baseline to endpoint in Patient Preference Scale (PPS) scores. [ Time Frame: 28 days ]
  • Change from baseline to endpoint in Life Skills Profile (LSP). [ Time Frame: 28 days ]
  • Change from baseline in Outcome Resource Discharge Questionnaire (ORDQ) scores on Days 2, 4, 7, 14, 21, and 28. [ Time Frame: 28 days ]
  • Change from baseline to endpoint in Cognitive Battery. [ Time Frame: 28 days ]
  • Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS total scores. [ Time Frame: 28 days ]
  • 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 ]
  • Adverse events, laboratory evaluations, vital signs, electrocardiograms at baseline and on Days 2, 4, 7, 14, 21, and 28. [ Time Frame: 28 days ]
  • Change from baseline to Day 28 in movement disorder rating scale scores. [ Time Frame: 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing the Efficacy and Safety of Ziprasidone and Aripiprazole for the Treatment fo Schizophrenia or Schizoaffective Disorder in Hospitalized Patients
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Aripiprazole
    Intervention: Drug: Aripiprazole
  • Active Comparator: Ziprasidone
    Intervention: Drug: Ziprasidone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2008)
256
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00634348
Other Study ID Numbers  ICMJE A1281110
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP