Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed) - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00265330

Purpose

The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed)

Condition	Intervention	Phase
Bipolar Disorder	Drug: Ziprasidone oral capsules	Phase III

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Ziprasidone Ziprasidone hydrochloride Ziprasidone mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	26-Week Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety assessments, including adverse events, electrocardiographic assessments, physical exam, and laboratory measures- done monthly [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

CGI S,CDRS R, Movement disorder scales (SARS, BAS, AIMS)-done monthly CGAS,YMRS,CPBAQ done at weeks 2, 6, 18, and 26 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
CHQ, School Placement Questionnaire, CNS Vital Signs Battery and Sedation item done at weeks 6 and 26 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Tanner Adolescent Pubertal Self Assessment-only done week 26 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	169
Study Start Date:	March 2006
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
open	Drug: Ziprasidone oral capsules Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid .

Eligibility

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

Criteria

Inclusion Criteria:

Participation in double-blind treatment study A1281132, meeting specific criteria of duration and safety

Exclusion Criteria:

Imminent risk of suicide or homicide, as judged by the site investigator;serious adverse event related to study medication in study A1281132; significant prolongation of QT interval in study A1281132.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265330

Show 41 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:	A1281133
Study First Received:	December 12, 2005
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00265330
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

Study placed in the following topic categories:

Affective Disorders, Psychotic
Dopamine
Mental Disorders
Bipolar Disorder

Mood Disorders
Psychotic Disorders
Ziprasidone
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
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
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009