Treatment of Schizophrenic Patients With Ziprasidone - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00579670

Purpose

To determine whether ziprasidone provides good efficacy and tolerability in the treatment of schizophrenic Greek patients.

Condition	Intervention	Phase
Schizophrenia	Drug: Ziprasidone	Phase IV

MedlinePlus related topics: Schizophrenia

Drug Information available for: Ziprasidone Ziprasidone hydrochloride Ziprasidone mesylate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Treatment of Schizophrenic Patients With Geodon; Capsules/Oral Suspension/Solution for Injection (Ziprasidone)

Further study details as provided by Pfizer:

Primary Outcome Measures:

To identify the clinical profile of the patients administered Ziprasidone for schizophrenia [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the severity of schizophrenia , among the study population [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To determine the daily dosage and formulation of Ziprasidone that is being used [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To determine how treatment satisfaction is rated by the patient using theTreatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To determine body weight development seen during treatment with Ziprasidone [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
To determine if treatment with Ziprasidone had to be stopped prematurely [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To determine the frequency of previously diagnosed (before the visit) metabolic risk factors in schizophrenic patients [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To determine how the overall efficacy and tolerability of Ziprasidone is rated by the physician [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
To determine what the change in the severity of the condition as well as clinical improvement of symptoms is rated using global assessments by the physician [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To determine whether treatment decision with Ziprasidone was made on the basis of metabolic risk factors of the patient [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	450
Study Start Date:	October 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Ziprasidone 20mg, 40mg, 60mg, 80mg capsules, hard; Ziprasidone 10 mg/ml oral suspension Ziprasidone 20mg/ml powder and solvent for the reconstitution of solution for injection

Detailed Description:

Non-interventional study (subjects chosen by physician in accordance to their usual practice

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients diagnosed with schizophrenia

Criteria

Inclusion Criteria:

Usual clinical practice of physician

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579670

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure )
Study ID Numbers:	A1281156
Study First Received:	December 20, 2007
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00579670
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Pfizer:

Ziprasidone in patients with schizophrenia

Study placed in the following topic categories:

Schizophrenia
Dopamine
Mental Disorders
Psychotic Disorders

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 January 16, 2009