A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00644800

Purpose

To assess the efficacy, safety, and tolerability of intramuscular ziprasidone in the treatment of the acute exacerbation of non-organic psychosis of any etiology, including schizophrenia, acute mania, delusional disorder and others.

Condition	Intervention	Phase
Schizophrenia Mania Delusional Disorder Acute Exacerbation of Psychosis	Drug: Ziprasidone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open, Multicenter, Non-Comparative Study To Assess The Efficacy And Tolerability Of Intramuscular Ziprasidone Followed By Oral Ziprasidone In Patients With Acute Psychosis

Resource links provided by NLM:

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Ziprasidone hydrochloride Ziprasidone Ziprasidone mesylate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in Positive and Negative Syndrome Scale (PANSS) excitation items scores [ Time Frame: Days 1-3 (end of intramuscular dosing) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Electrocardiogram at Visits 1 and 5 [ Time Frame: Visits 1 (Screening) and 5 (Day 7) ] [ Designated as safety issue: Yes ]
Adverse events at Visits 2, 3, 4, and 5 [ Time Frame: Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7) ] [ Designated as safety issue: Yes ]
Change from baseline in Patient Preference Scale (PPS) scores at Visits 3 and 5 [ Time Frame: Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4) and 5 (Day 7) ] [ Designated as safety issue: No ]
Laboratory tests at Visits 1 and 5 [ Time Frame: Visits 1 (Screening) and 5 (Day 7) ] [ Designated as safety issue: Yes ]
Movement disorder rating scale scores (Barnes Akathisia Scale and Extrapyramidal Symptoms Rating Scale) at Visits 2, 3, 4, and 5 [ Time Frame: Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7) ] [ Designated as safety issue: Yes ]
Change from baseline in PANSS excitation items scores at Visits 3, 4, and 5 [ Time Frame: Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7) ] [ Designated as safety issue: No ]
Blood pressure and pulse at Visits 1, 2, and 5 [ Time Frame: Visits 1 (Screening), 2 (Day 1), and 5 (Day 7) ] [ Designated as safety issue: Yes ]
Change from baseline in Clinical Global Impression-Severity (CGI-S) scores at Visits 3, 4, and 5 [ Time Frame: Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7) ] [ Designated as safety issue: No ]

Enrollment:	89
Study Start Date:	July 2003
Study Completion Date:	May 2004

Arms	Assigned Interventions
Arm A: Experimental	Drug: Ziprasidone Intramuscular ziprasidone 10 or 20 mg at the investigator's discretion for 1 to 3 days followed by oral ziprasidone capsules 40 to 80 mg twice daily at the investigator's discretion to complete 7 days of treatment

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hospitalized patients with psychosis
Eligible for intramuscular treatment
Miminum score of 60 on the PANSS, a score of 14 in the sum of PANSS excitation score and a score of at least 4 in 1 of the following items: poor control of impulses, tension, hostility, uncooperativeness or excitation.

Exclusion Criteria:

Treatment with antidepressants or mood stabilizers within seven days prior to the enrollment; for monoamine oxidase inhibitors (MAOIs) and moclobemide, this period must be two weeks; for fluoxetine, five weeks
Resistance to conventional antipsychotic agents
A history of epilepsy
A diagnosis of abuse of substance within the previous 3 months according to the DSMIV criteria.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644800

Locations

Brazil, BAHIA
Pfizer Investigational Site
SALVADOR, BAHIA, Brazil, 41180-000
Brazil, CEARA
Pfizer Investigational Site
FORTALEZA, CEARA, Brazil, 60175-270
Brazil, mg
Pfizer Investigational Site
BELO HORIZONTE, mg, Brazil, 30150-270
Brazil, PR
Pfizer Investigational Site
Curitiba, PR, Brazil
Brazil, RJ
Pfizer Investigational Site
RIO DE JANEIRO, RJ, Brazil
Pfizer Investigational Site
SAO GONCALO, RJ, Brazil
Brazil, Salvador - Ba
Pfizer Investigational Site
JARDIM SANTA MONICA SN, Salvador - Ba, Brazil, 40340-720
Brazil, SP
Pfizer Investigational Site
SAO PAULO, SP, Brazil

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:	A1281074
Study First Received:	March 20, 2008
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00644800 History of Changes
Health Authority:	Brazil: National Health Surveillance Agency

Study placed in the following topic categories:

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

Dopamine
Delusions
Mental Disorders
Dopamine Agents
Psychotic Disorders
Ziprasidone
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
Schizophrenia

Schizophrenia, Paranoid
Serotonin Antagonists
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 September 10, 2009