Trials / Completed
CompletedNCT00257166
Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 238 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- 10 Years – 17 Years
- Healthy volunteers
- Not accepted
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 I disorder (manic or mixed).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ziprasidone oral capsules | Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID. |
| DRUG | placebo oral capsules | Oral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID. |
Timeline
- Start date
- 2006-01-01
- Primary completion
- 2007-07-01
- Completion
- 2007-07-01
- First posted
- 2005-11-22
- Last updated
- 2021-03-03
- Results posted
- 2013-07-19
Locations
50 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00257166. Inclusion in this directory is not an endorsement.