WithdrawnPhase 3

Safety And Efficacy Of Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) (Protocol A1281196)

0Started 2010-06

Plain-language summary

The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with Bipolar l Disorder (Manic or Mixed).

Who can participate

Age range10 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria for Bipolar I disorder (manic or mixed) * At the screening and baseline visits, subjects must have a Young Mania Rating Scale (YMRS) score of at least 17. * The subject must have a Body Mass Index (BMI) z score between -1.65 and +2.00, inclusive Exclusion Criteria: * Imminent risk of suicide or homicide, as judged by the site investigator * Any history of serious or unstable illness * Risk for prolonged QT

What they're measuring

Change from baseline to Week 4 in Young Mania Rating Scale (YMRS) total score.

Timeframe: 4 weeks

Trial details

NCT IDNCT01117220

SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-04

View on ClinicalTrials.gov More Bipolar Disorder trials