Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

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

Overview

The purpose of this study is to assess the safety and tolerability of ziprasidone during a long-term open label study in children and adolescents (ages 10-17) with Bipolar I Disorder (Manic or Mixed).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Bipolar Disorder

Interventions

ziprasidone oral capsulesDRUG

Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength will be provided. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 40mg twice a day (BID) to a maximum dose range of 80 mg BID. For subjects weighing \<45 kg, the doses will range from 20 mg BID to 40 mg BID.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The subjects must have received study medication in Study A1281196. * In the investigator's opinion, the subject must be likely to continue to benefit from antipsychotic therapy and must have been free from any clinically significant safety concerns during the preceding double blind study. Exclusion Criteria: * Subjects who require treatment with drugs that are known to consistently prolong the QT interval. * Subjects who are judged by the investigator as being at imminent risk of suicide.

Outcomes

Primary Outcomes

Change from Baseline in blood pressure and pulse Change from baseline in electrocardiogram (QTc) Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S)

Time frame: weeks 1, 2, 6, 10, 14, 18, 22, and 26

Change from baseline in Physical exam

Time frame: week 26

Change from baseline in Clinical laboratory tests

Time frame: weeks 2, 6, 18,26

Change from baseline in body weight, height, BMI, BMI z score, and waist circumference

Time frame: weeks 6, 26

Adverse events -Only number of subjects with adverse events or serious adverse events Columbia Suicide Severity Rating Scale Change from Baseline in Child Depression Rating Scale - Revised (CDRS-R)

Time frame: weeks 1, 2, 6, 10, 14, 18, 22, and 26

Secondary Outcomes

Change from Baseline in Young Mania Rating Scale (YMRS)

Time frame: weeks 2, 6, 18, and 26

Change from Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ)

Time frame: weeks 2, 6, 18, and 26

Change from Baseline in Child Health Questionnaire

Time frame: weeks 6 and 26

Change from Baseline in School Placement Questionnaire

Time frame: weeks 6 and 26

Change from Baseline in CNS Vital Signs Cognitive Test Battery

Data from ClinicalTrials.gov

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