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Efficacy and Safety Trial of ...

Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder

NCT ID: NCT02075047

Last Updated: 2021-06-16

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-23

Study Completion Date

2020-05-18

Brief Summary

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The purpose of this study is to determine if ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).

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Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

placebo oral capsules

Intervention Type DRUG

Placebo matching the oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dosing design. Dosing is stratified based on weight, with subjects \<45 kg having a target dose range of 60-80 mg/day and subjects \>/= 45 kg having a target dose range of 120-180 mg/day.

ziprasidone

Group Type EXPERIMENTAL

ziprasidone oral capsules

Intervention Type DRUG

Oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dosing design. Dosing is stratified based on weight, with subjects \<45 kg having a target dose range of 60-80 mg/day and subjects \>/= 45 kg having a target dose range of 120-180 mg/day.

Interventions

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placebo oral capsules

Intervention Type DRUG

ziprasidone oral capsules

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* DSM V criteria for Bipolar I disorder (manic or mixed); age 10 - 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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Harmonex Neuroscience Research, Inc.

Dothan, Alabama, United States

Site Status

Woodland International Research Group Inc.

Little Rock, Arkansas, United States

Site Status

Woodland International Research Group, LLC

Little Rock, Arkansas, United States

Site Status

California Pharmaceutical Research Institute

Anaheim, California, United States

Site Status

NRC Research Institute

Orange, California, United States

Site Status

Asclepes Research Centers

Panorama City, California, United States

Site Status

University of California Davis Medical Center MIND Institute

Sacramento, California, United States

Site Status

Elite Clinical Trials, Incorporated

Wildomar, California, United States

Site Status

Children's National Health System

Washington D.C., District of Columbia, United States

Site Status

Da Vinci Research Institute Inc

Boca Raton, Florida, United States

Site Status

Sarkis Clinical Trials

Gainesville, Florida, United States

Site Status

Medical Research Group of Central Florida

Orange City, Florida, United States

Site Status

APG Research LLC

Orlando, Florida, United States

Site Status

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Site Status

Inova Clinical Trials and Research Centre

Fayetteville, Georgia, United States

Site Status

Attalla Consultants, LLC dba Institute for Behavioral Medicine

Smyrna, Georgia, United States

Site Status