NCT01117220

Brief Summary

The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with Bipolar l Disorder (Manic or Mixed).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_3

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
27 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

May 3, 2010

Last Update Submit

February 18, 2021

Conditions

Bipolar Disorder

Keywords

pediatricbipolar

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to Week 4 in Young Mania Rating Scale (YMRS) total score.

    4 weeks

Secondary Outcomes (2)

  • Change from baseline in Clinical Global Impression of Severity (CGI S) score.

    4 weeks

  • Clinical Global Impression of Improvement (CGI I) score

    4 weeks

Study Arms (2)

2

PLACEBO COMPARATOR
Drug: Placebo

1

ACTIVE COMPARATOR
Drug: Ziprasidone Oral Capsules

Interventions

PlaceboDRUG

Placebo matching the oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dose design with minimal dose range of 40 mg twice a day (BID) to maximum dose range of 80 mg BID (weight specific- \< 45kg max dose 40 mg BID).

2
Ziprasidone Oral CapsulesDRUG

Oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dose design with minimal dose range of 40 mg twice a day (BID to maximum dose range of 80 mg BID (weight specific- \< 45kg max dose 40 mg BID).

Also known as: Geodon, Zeldox
1

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria for Bipolar I disorder (manic or mixed)
  • At the screening and baseline visits, subjects must have a Young Mania Rating Scale (YMRS) score of at least 17.
  • The subject must have a Body Mass Index (BMI) z score between -1.65 and +2.00, inclusive

You may not qualify if:

  • Imminent risk of suicide or homicide, as judged by the site investigator
  • Any history of serious or unstable illness
  • Risk for prolonged QT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Bipolar Disorder

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2010

First Posted

May 5, 2010

Study Start

June 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

February 21, 2021

Record last verified: 2021-02