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

NCT01124877 | Withdrawn Phase 3 DMC

• 1 other identifier: A1281197
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Bipolar Disorder

Keywords

Children and Adolescents with Bipolar I Disorder (manic or mixed)

Outcome Measures

Primary Outcomes (5)

• 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)

  weeks 1, 2, 6, 10, 14, 18, 22, and 26

• Change from baseline in Physical exam

  week 26

• Change from baseline in Clinical laboratory tests

  weeks 2, 6, 18,26

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

  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)

  weeks 1, 2, 6, 10, 14, 18, 22, and 26

Secondary Outcomes (11)

• Change from Baseline in Young Mania Rating Scale (YMRS)

  weeks 2, 6, 18, and 26

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

  weeks 2, 6, 18, and 26

• Change from Baseline in Child Health Questionnaire

  weeks 6 and 26

• Change from Baseline in School Placement Questionnaire

  weeks 6 and 26

• Change from Baseline in CNS Vital Signs Cognitive Test Battery

  weeks 6 and 26

Study Arms (1)

Open

OTHER

Drug: ziprasidone oral capsules

Interventions

ziprasidone oral capsules DRUG

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.

Also known as: Zeldox, Geodon

Open

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Bipolar Disorder; Mania

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2010
• First Posted: May 17, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 21, 2021

Record last verified: 2021-02