Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00257166 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 3
- Development phase
- 238
- Enrollment target
NCT00257166: Completed Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00257166 is a Phase 3 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 238 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00257166, a Phase 3 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 238 participants
- Enrollment target
Study 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).
Primary Outcome
YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.
Interventions
- DRUG Ziprasidone oral capsules
- DRUG placebo oral capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 238 participants |
| Start Date | 2006-01 |
| Est. Completion | 2007-07 |
| Phase | Phase 3 |
What the finished NCT00257166 record still lists
NCT00257166 is an interventional study that assigns participants to a tested intervention. The registered 238 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Ziprasidone oral capsules is the first listed.
NCT00257166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00257166 about?
NCT00257166 is a clinical study titled "Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)". 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).
What is the current status of trial NCT00257166?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 238 participants. The study started on 2006-01. Estimated completion is 2007-07.
What interventions are being tested in trial NCT00257166?
The interventions under investigation include: Ziprasidone oral capsules (DRUG), placebo oral capsules (DRUG).
Who is sponsoring clinical trial NCT00257166?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00257166's enrollment target sits among peer trials
238 1291st of 2000 higher than 708 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05012072 · 238 participants · NA
Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
- NCT05400252 · 238 participants · NA
Whole Health in VA Mental Health: Omnis Salutis
- NCT06380517 · 238 participants · Phase 3
Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
- NCT06452797 · 238 participants · NA
Prognostic Estimates Among ICU Clinicians
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia