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

Last updated on June 16, 2018

FOR MORE INFORMATION
Study Location
Harmonex Neuroscience Research, Inc.
Dothan, Alabama, 36303 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bipolar Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- DSM V criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Imminent risk of suicide or homicide, as judged by the site investigator; any history
of serious or unstable medical illness, including risk for QT prolongation.

NCT02075047
Pfizer
Recruiting
Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder

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Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder
A Phase 3, Multicenter, Four-week, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy And Safety Trial Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Current Or Most Recent Episode Manic)
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Bipolar Disorder
  • 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.
  • Placebo Comparator: 1
    Intervention: Drug: placebo oral capsules
  • Experimental: ziprasidone
    Intervention: Drug: ziprasidone oral capsules
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
October 10, 2021
October 4, 2021   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • DSM V criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years.

Exclusion Criteria:

  • Imminent risk of suicide or homicide, as judged by the site investigator; any history of serious or unstable medical illness, including risk for QT prolongation.
Sexes Eligible for Study: All
10 Years to 17 Years   (Child)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT02075047
A1281198
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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