Safety And Efficacy Of Ziprasidone In Children And Adoles... | NCT01117220

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

NCT01117220

Sponsor

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

Status

Withdrawn

Last Update Posted

Feb 21, 2021Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Bipolar Disorder

Interventions

Placebo
Ziprasidone Oral Capsules

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Apr 2011Estimated

Completion Date

Apr 2011Estimated

First Submitted Date

May 3, 2010

First Submission Date that Met QC Criteria

May 3, 2010

First Posted Date

May 5, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2021

Last Update Posted Date

Feb 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Placebo Comparator		Drug: Placebo
1	Active Comparator		Drug: Ziprasidone Oral Capsules

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline to Week 4 in Young Mania Rating Scale (YMRS) total score.		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in Clinical Global Impression of Severity (CGI S) score.		4 weeks
Clinical Global Impression of Improvement (CGI I) score		4 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

References Module

Citations

Not provided

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders