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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Ziprasidone hydrochloride Ziprasidone Ziprasidone mesylate

U.S. FDA Resources

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 ]

Enrollment:	285
Study Start Date:	February 2006
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (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 .

Detailed Description:

Termination Reason: On March 24, 2009, Pfizer Inc. stopped late stage Geodon pediatric clinical trials in schizophrenia (A1281134 - placebo controlled; A1281135 - open label). As recommended by the DSMB, these studies were stopped due to lack of efficacy. No safety concerns were identified.

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

Show 93 Study Locations

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:	A1281134
Study First Received:	November 21, 2005
Last Updated:	May 7, 2009
ClinicalTrials.gov Identifier:	NCT00257192 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Adolescent Subjects With Schizophrenia

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

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

ClinicalTrials.gov processed this record on September 11, 2009