A Study of the Efficacy and Safety of Ziprasidone for the Treatment of Acute Exacerbation of Schizophrenia or Schizoaffective Disorder - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00650429

Purpose

This study was conducted to examine the efficacy and tolerability of ziprasidone intramuscular (IM), and to assess the effect of switching from IM to oral ziprasidone for the treatment of acute exacerbation of schizophrenia and schizoaffective disorder in a Latin American population.

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder	Drug: Ziprasidone	Phase IV

MedlinePlus related topics: Schizophrenia

Drug Information available for: Ziprasidone hydrochloride Ziprasidone Ziprasidone mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Ziprasidone Intramuscular/Oral In The Treatment Of Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder: A Six-Week Open Administration Study

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline to endpoint in Brief Psychiatric Rating Scale (BPRS) total score [ Time Frame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale score [ Time Frame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) ] [ Designated as safety issue: No ]
Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scale score [ Time Frame: Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) ] [ Designated as safety issue: No ]
Simpson-Angus Scale (SAS) [ Time Frame: Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO) ] [ Designated as safety issue: Yes ]
Barnes Akathisia Scale (BAS) [ Time Frame: Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO) ] [ Designated as safety issue: Yes ]
Laboratory tests [ Time Frame: Screening and Week 6 ] [ Designated as safety issue: Yes ]
Electrocardiogram [ Time Frame: Screening and Week 6 ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) ] [ Designated as safety issue: Yes ]
Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Day 1 (IM), Day 4 (Switch), and Week 6 (PO) ] [ Designated as safety issue: Yes ]
Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) ] [ Designated as safety issue: No ]
Change from baseline to endpoint in Covi Anxiety Scale score [ Time Frame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) ] [ Designated as safety issue: No ]
Change from baseline to endpoint in Positive PANSS subscale score [ Time Frame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) ] [ Designated as safety issue: No ]
Change from baseline to endpoint in Negative PANSS subscale score [ Time Frame: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO) ] [ Designated as safety issue: No ]

Enrollment:	28
Study Start Date:	October 2003
Study Completion Date:	May 2005

Arms	Assigned Interventions
Arm A: Experimental	Drug: Ziprasidone IM ziprasidone at an initial dose of 10 or 20 mg for the first 3 days; additional doses could be administered according to clinical need, with the maximum total daily IM dose of 40 mg. On Day 4, IM treatment was switched to oral (PO) treatment at an initial dose of 40 mg twice daily for the first 2 days; doses could be subsequently adjusted within the range of 40 to 80 mg twice daily. Total treatment duration was 6 weeks.

Arms

Assigned Interventions

Arm A: Experimental

Drug: Ziprasidone

IM ziprasidone at an initial dose of 10 or 20 mg for the first 3 days; additional doses could be administered according to clinical need, with the maximum total daily IM dose of 40 mg. On Day 4, IM treatment was switched to oral (PO) treatment at an initial dose of 40 mg twice daily for the first 2 days; doses could be subsequently adjusted within the range of 40 to 80 mg twice daily. Total treatment duration was 6 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of schizophrenia or schizoaffective disorder.
Inpatients with acute exacerbation of psychotic symptoms.
Patients with a minimum score of 40 on the BPRS scale (1-7).

Exclusion Criteria:

Concurrent treatment with antipsychotic agents at study drug initiation (within 12 hours prior to study drug initiation); for depot agents a period of two weeks or one cycle, whichever is the longer, must occur between last administration and study drug initiation.
Treatment with antidepressants or mood stabilizers within 7 days of start of ziprasidone.
Patients currently receiving clozapine.
Patients at immediate risk of committing harm to self or others.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650429

Locations

Mexico
Pfizer Investigational Site
DF, Mexico, 14420
Pfizer Investigational Site
Mexico D F, Mexico, 14269
Pfizer Investigational Site
MEXICO CITY, Mexico, 14050
Mexico, NUEVO LEON
Pfizer Investigational Site
MONTERREY, NUEVO LEON, Mexico, 64800

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional 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

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1281056
Study First Received:	March 28, 2008
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00650429 History of Changes
Health Authority:	Mexico: Federal Commission for Sanitary Risks Protection

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Serotonin
Schizophrenia

Dopamine
Mental Disorders
Psychotic Disorders
Dopamine Agents
Ziprasidone
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Schizophrenia

Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Mental Disorders
Therapeutic Uses
Dopamine Agents
Psychotic Disorders
Ziprasidone
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009