A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00650611

Purpose

The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in children and teens with psychotic disorders

Condition	Intervention	Phase
Schizophrenia Bipolar Disorder Schizoaffective Disorder	Drug: Ziprasidone	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 27-Week Open-Label Trial To Characterize The Safety And Tolerability Of Orally Administered Ziprasidone In Children And Adolescent Subjects With Bipolar I Disorder (Manic Or Mixed), Schizophrenia Or Schizoaffective Disorder

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder 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:

Adverse events at Baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27. [ Time Frame: 27 weeks ] [ Designated as safety issue: Yes ]
Electrocardiograms and vital signs at Screening, baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27. [ Time Frame: 27 weeks ] [ Designated as safety issue: Yes ]
Laboratory data at Screening and Weeks 3, 12, and 27. [ Time Frame: 27 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical Global Impressions-Improvement (CGI-I) scale scores on Day 4 and at Weeks 1, 2, and 3. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Mean change from baseline in Childrens' Global Assessment Scale (CGAS) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27. [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
Serum concentrations of ziprasidone and its major metabolites at Weeks 1, 3, 12, and 27. [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
Mean change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores on Day 4 and at Weeks 1, 2, 3, 12, and 27. [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
Mean change from baseline in Young Mania Rating Scale (YMRS) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27. [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
Mean change from baseline in Brief Psychiatric Rating Scale-Anchored (BPRS-A) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27. [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
Mean change from baseline in movement disorder rating scale scores at Weeks 3, 12, and 27. [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]

Enrollment:	63
Study Start Date:	December 2003
Study Completion Date:	March 2005

Arms	Assigned Interventions
Low-Dose Ziprasidone: Active Comparator	Drug: Ziprasidone Period 1: Initial dose of oral ziprasidone suspension 10 mg twice daily, which was titrated up in 10 mg twice daily increments to a maximum dose of 40 mg twice daily by Day 10. Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period 1.
High-Dose Ziprasidone: Active Comparator	Drug: Ziprasidone Period 1: Initial dose of oral ziprasidone suspension 20 mg twice daily, which was titrated up in 20 mg twice daily increments to a maximum dose of 80 mg twice daily by Day 10. Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period 1.

Arms

Assigned Interventions

Low-Dose Ziprasidone: Active Comparator

Drug: Ziprasidone

Period 1: Initial dose of oral ziprasidone suspension 10 mg twice daily, which was titrated up in 10 mg twice daily increments to a maximum dose of 40 mg twice daily by Day 10. Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period

1.

High-Dose Ziprasidone: Active Comparator

Drug: Ziprasidone

Period 1: Initial dose of oral ziprasidone suspension 20 mg twice daily, which was titrated up in 20 mg twice daily increments to a maximum dose of 80 mg twice daily by Day 10. Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period

1.

Eligibility

Ages Eligible for Study:	10 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children and teens with Bipolar I Disorder (manic or mixed), schizophrenia or schizoaffective disorder
Willingness to discontinue all antipsychotic medications during the study period

Exclusion Criteria:

Patients who are clinically stable on treatments that are well tolerated
Substance-induced psychotic disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650611

Locations

United States, California
Pfizer Investigational Site
San Diego, California, United States, 92111
United States, Florida
Pfizer Investigational Site
Altamonte Springs, Florida, United States, 32701
United States, Illinois
Pfizer Investigational Site
Libertyville, Illinois, United States, 60048
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40509
United States, Massachusetts
Pfizer Investigational Site
Belmont, Massachusetts, United States, 02478
Pfizer Investigational Site
Brighton, Massachusetts, United States, 02135
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89103
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89117
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Pfizer Investigational Site
Turnersville, New Jersey, United States, 08012
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45224
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45229
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45267-0559
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104-3309
United States, Washington
Pfizer Investigational Site
Kirkland, Washington, United States, 98033
Pfizer Investigational Site
Kirkland, Washington, United States, 98034

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:	A1281123
Study First Received:	March 28, 2008
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00650611 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Bipolar Disorder
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Serotonin
Schizophrenia
Affective Disorders, Psychotic

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

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on September 11, 2009