MedTrace Logo

Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder

NCT02075047 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2021-06-16

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine if ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).

Conditions

Interventions

DRUG

placebo oral capsules

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 dosing design. Dosing is stratified based on weight, with subjects \<45 kg having a target dose range of 60-80 mg/day and subjects \>/= 45 kg having a target dose range of 120-180 mg/day.

DRUG

ziprasidone oral capsules

Oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dosing design. Dosing is stratified based on weight, with subjects \<45 kg having a target dose range of 60-80 mg/day and subjects \>/= 45 kg having a target dose range of 120-180 mg/day.

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-23
Primary Completion
2020-04-11
Completion
2020-05-18
FDA Drug
Yes

Countries

  • United States
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02075047 on ClinicalTrials.gov