Bipolar Disorder
Conditions
Keywords
pediatric, bipolar
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).
Interventions
DRUGPlacebo
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).
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).
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 4 in Young Mania Rating Scale (YMRS) total score. | 4 weeks |
Secondary
| Measure | 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 |
Outcome results
None listed