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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01124877
First received: May 14, 2010
Last updated: January 17, 2013
Last verified: January 2013
History of Changes

May 14, 2010
January 17, 2013
July 2010
October 2011   (final data collection date for primary outcome 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) [ Time Frame: weeks 1, 2, 6, 10, 14, 18, 22, and 26 ] [ Designated as safety issue: Yes ]
  • Change from baseline in Physical exam [ Time Frame: week 26 ] [ Designated as safety issue: Yes ]
  • Change from baseline in Clinical laboratory tests [ Time Frame: weeks 2, 6, 18,26 ] [ Designated as safety issue: Yes ]
  • Change from baseline in body weight, height, BMI, BMI z score, and waist circumference [ Time Frame: weeks 6, 26 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01124877 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Young Mania Rating Scale (YMRS) [ Time Frame: weeks 2, 6, 18, and 26 ] [ Designated as safety issue: No ]
  • Change from Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) [ Time Frame: weeks 2, 6, 18, and 26 ] [ Designated as safety issue: No ]
  • Change from Baseline in Child Health Questionnaire [ Time Frame: weeks 6 and 26 ] [ Designated as safety issue: No ]
  • Change from Baseline in School Placement Questionnaire [ Time Frame: weeks 6 and 26 ] [ Designated as safety issue: No ]
  • Change from Baseline in CNS Vital Signs Cognitive Test Battery [ Time Frame: weeks 6 and 26 ] [ Designated as safety issue: No ]
  • Change from Baseline in CNS Vital Signs Cognitive Test Sedation Item [ Time Frame: weeks 6 and 26 ] [ Designated as safety issue: No ]
  • Change from Baseline in Simpson-Angus Rating Scale (SARS) [ Time Frame: weeks 1, 2, 6, 10, 14, 18, 22 and 26 ] [ Designated as safety issue: No ]
  • Change from Baseline in Barnes Akathisia Rating Scale (BAS) [ Time Frame: weeks 1, 2, 6, 10, 14, 18, 22 and 26 ] [ Designated as safety issue: No ]
  • Change from Baseline in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: weeks 1, 2, 6, 10, 14, 18, 22 and 26 ] [ Designated as safety issue: No ]
  • Change from Baseline in Childrens Global Assessment Scales [ Time Frame: weeks 2, 6, 18, and 26 ] [ Designated as safety issue: No ]
  • Change from Baseline in Tanner Adolescent Pubertal Self-Assessment [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
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)

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).
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bipolar Disorder
Drug: ziprasidone oral capsules
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.
Other Name: Zeldox, Geodon
Open
Intervention: Drug: ziprasidone oral capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
10 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01124877
A1281197
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP