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This study has been withdrawn prior to enrollment.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
  Purpose

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).


Condition Intervention Phase
Bipolar Disorder
Drug: ziprasidone oral capsules
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: July 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Open 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

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124877

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01124877     History of Changes
Other Study ID Numbers: A1281197
Study First Received: May 14, 2010
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Children and Adolescents with Bipolar I Disorder (manic or mixed)

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on April 21, 2014