Safety and Efficacy of Ziprasidone in Adolescents With Schizophrenia - Full Text View

Purpose

The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of adolescents (ages 13-17) with schizophrenia

Condition	Intervention	Phase
Schizophrenia	Drug: placebo Drug: Ziprasidone oral capsules	Phase III

MedlinePlus related topics:

Schizophrenia

ChemIDplus related topics:

Ziprasidone Ziprasidone hydrochloride Ziprasidone mesylate

U.S. FDA Resources

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

Official Title:	Six Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Adolescent Subjects With Schizophrenia

Further study details as provided by Pfizer:

Primary Outcome Measures:

Brief Psychiatric Rating Scale - Anchored [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SARS, BAS, AIMS, CNS Vitals including Sedation, CDRS-R, CPBAQ, School Placement, CHQ, CGAS [ Time Frame: 6 week ] [ Designated as safety issue: No ]
CGI-S, Tanner Staging, [ Time Frame: 6 week ] [ Designated as safety issue: No ]
Positive and Negative Syndrome Scale; Clinical Global Impression scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	276
Study Start Date:	February 2006
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2.0: Placebo Comparator	Drug: placebo Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength or matching placebo. Subjects will be dosed daily for 6 weeks using a flexible dose design with a minimal dose range of 40mg bid to a maximum dose range of 80 mg bid .
1.0: Active Comparator	Drug: Ziprasidone oral capsules Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength or matching placebo. Subjects will be dosed daily for 6 weeks using a flexible dose design with a minimal dose range of 40mg bid to a maximum dose range of 80 mg bid .

Eligibility

Ages Eligible for Study:	13 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

DSM-IV criteria for schizophrenia; age 13 - 17 years

Exclusion Criteria:

Imminent risk of suicide or homicide, as judged by the site investigator; any history of serious or unstable medical illness, including risk for QT prolongation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257192

Contacts


Contact: Pfizer CT.gov Call Center	1-800-718-1021

Show 102 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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1281134
First Received:	November 21, 2005
Last Updated:	August 29, 2008
ClinicalTrials.gov Identifier:	NCT00257192
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Adolescent Subjects 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 September 19, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00257192