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

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 IV

MedlinePlus related topics:

Schizophrenia

ChemIDplus related topics:

Ziprasidone Ziprasidone hydrochloride Ziprasidone mesylate Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

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

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
Aripiprazole: Active Comparator	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
Ziprasidone: Active Comparator	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

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

Show 42 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:

Schizophrenia

Dopamine

Mental Disorders

Psychotic Disorders

Aripiprazole

Ziprasidone

Serotonin

Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Dopamine Antagonists

Antipsychotic Agents

Pharmacologic Actions

Serotonin Antagonists

Serotonin Agents

Therapeutic Uses

Dopamine Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00634348