Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder
Public ClinicalTrials.gov record NCT03768726. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
26-WEEK OPEN-LABEL EXTENSION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF FLEXIBLE DOSES OF ORAL ZIPRASIDONE IN CHILDREN AND ADOLESCENTS WITH BIPOLAR I DISORDER (MOST RECENT EPISODE MANIC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This 26-week open-label extension study is designed to provide information on the safety and tolerability of oral ziprasidone (20-80 mg BID (twice daily) with meals) during long-term administration in children and adolescents with Bipolar I Disorder (current or most recent episode manic).
Study identification
- NCT ID
- NCT03768726
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 23 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 10 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 21, 2018 (Actual)
- Primary completion
- Jul 31, 2020 (Actual)
- Completion
- Jul 31, 2020 (Actual)
- Last update posted
- Jun 16, 2021
2018 – 2020
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | — |
| Inova Clinical Trials and Research Centre | Fayetteville | Georgia | 30214 | — |
| Attalla Consultants, LLC dba Institute for Behavioral Medicine | Smyrna | Georgia | 30082-2629 | — |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | — |
| University of Cincinnati | Cincinnati | Ohio | 45219 | — |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | — |
| AIM Trials, LLC | Plano | Texas | 75093 | — |
| Family Psychiatry of the Woodlands | The Woodlands | Texas | 77381 | — |
| Eastside Therapeutic Resource Inc dba Core Clinical Research | Everett | Washington | 98201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03768726, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 16, 2021 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03768726 live on ClinicalTrials.gov.