Clinical trial NCT01124877: Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: Children and Adolescents with Bipolar I Disorder (manic or mixed)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-05-17
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: weeks 1, 2, 6, 10, 14, 18, 22, and 26
measure: Change from baseline in Physical exam
timeFrame: week 26
measure: Change from baseline in Clinical laboratory tests
timeFrame: weeks 2, 6, 18,26
measure: Change from baseline in body weight, height, BMI, BMI z score, and waist circumference
timeFrame: weeks 6, 26
measure: 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)
timeFrame: weeks 1, 2, 6, 10, 14, 18, 22, and 26
Secondary outcomes:
measure: Change from Baseline in Young Mania Rating Scale (YMRS)
timeFrame: weeks 2, 6, 18, and 26
measure: Change from Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ)
timeFrame: weeks 2, 6, 18, and 26
measure: Change from Baseline in Child Health Questionnaire
timeFrame: weeks 6 and 26
measure: Change from Baseline in School Placement Questionnaire
timeFrame: weeks 6 and 26
measure: Change from Baseline in CNS Vital Signs Cognitive Test Battery
timeFrame: weeks 6 and 26
measure: Change from Baseline in CNS Vital Signs Cognitive Test Sedation Item
timeFrame: weeks 6 and 26
measure: Change from Baseline in Simpson-Angus Rating Scale (SARS)
timeFrame: weeks 1, 2, 6, 10, 14, 18, 22 and 26
measure: Change from Baseline in Barnes Akathisia Rating Scale (BAS)
timeFrame: weeks 1, 2, 6, 10, 14, 18, 22 and 26
measure: Change from Baseline in Abnormal Involuntary Movement Scale (AIMS)
timeFrame: weeks 1, 2, 6, 10, 14, 18, 22 and 26
measure: Change from Baseline in Childrens Global Assessment Scales
timeFrame: weeks 2, 6, 18, and 26
measure: Change from Baseline in Tanner Adolescent Pubertal Self-Assessment
timeFrame: 26 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: