Back to results

Safety And Efficacy Of Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) (Protocol A1281196)

Primary Purpose

Bipolar Disorder

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Placebo

Ziprasidone Oral Capsules

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring pediatric, bipolar

Eligibility Criteria

10 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Clinical Global Impression of Improvement (CGI I) score

Full Information

NCT ID

NCT01117220

First Posted

May 3, 2010

Last Updated

February 18, 2021

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT01117220

Brief Title

Safety And Efficacy Of Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) (Protocol A1281196)

Official Title

Four Week, Double Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Withdrawn

Study Start Date

June 2010 (undefined)

Primary Completion Date

April 2011 (Anticipated)

Study Completion Date

April 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder

Keywords

pediatric, bipolar

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Ziprasidone Oral Capsules

Other Intervention Name(s)

Geodon, Zeldox

Intervention Description

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).

Primary Outcome Measure Information:

Title

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

4 weeks

Title

Clinical Global Impression of Improvement (CGI I) score

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281196&StudyName=Safety%20And%20Efficacy%20Of%20Ziprasidone%20In%20Children%20And%20Adolescents%20With%20Bipolar%20I%20Disorder%20%28Manic%20Or%20Mixed%29%20%28Protocol%20A1281196%29

Description

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

Learn more about this trial

Safety And Efficacy Of Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) (Protocol A1281196)

We'll reach out to this number within 24 hrs