Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder
Public ClinicalTrials.gov record NCT02075047. 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
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT02075047
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 171 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
- May 23, 2014 (Actual)
- Primary completion
- Apr 11, 2020 (Actual)
- Completion
- May 18, 2020 (Actual)
- Last update posted
- Jun 16, 2021
2014 – 2020
United States locations
- U.S. sites
- 46
- U.S. states
- 15
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Harmonex Neuroscience Research, Inc. | Dothan | Alabama | 36303 | — |
| Woodland International Research Group Inc. | Little Rock | Arkansas | 72211 | — |
| Woodland International Research Group, LLC | Little Rock | Arkansas | 72211 | — |
| California Pharmaceutical Research Institute | Anaheim | California | 92804 | — |
| NRC Research Institute | Orange | California | 92868 | — |
| Asclepes Research Centers | Panorama City | California | 91402 | — |
| University of California Davis Medical Center MIND Institute | Sacramento | California | 95817 | — |
| Elite Clinical Trials, Incorporated | Wildomar | California | 92595 | — |
| Children's National Health System | Washington D.C. | District of Columbia | 20010 | — |
| Da Vinci Research Institute Inc | Boca Raton | Florida | 33487 | — |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | — |
| APG Research LLC | Orlando | Florida | 32803 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| Inova Clinical Trials and Research Centre | Fayetteville | Georgia | 30214 | — |
| Attalla Consultants, LLC dba Institute for Behavioral Medicine | Smyrna | Georgia | 30082-2629 | — |
| Sleep and Behavior Medicine Institute | Vernon Hills | Illinois | 60061 | — |
| Hugo W. Moser Research Institute at Kennedy Krieger Institute Clinical Trials Unit | Baltimore | Maryland | 21205 | — |
| Kennedy Krieger Institute Inpatient Clinic | Baltimore | Maryland | 21205 | — |
| Kennedy Krieger Institute Outpatient Clinic | Baltimore | Maryland | 21205 | — |
| Psychiatric Mental Health Program at Kennedy Krieger Institute Clinical Trials Unit | Baltimore | Maryland | 21205 | — |
| Johns Hopkins Hospital Pediatric Clinical Research Unit | Baltimore | Maryland | 21231 | — |
| Charlotte R. Bloomberg Children's Center | Baltimore | Maryland | 21287 | — |
| Johns Hopkins Hospital Investigational Drug Services | Baltimore | Maryland | 21287 | — |
| Clinical Research Integrity(CRI) Lifetree, LLC | Marlton | New Jersey | 08053 | — |
| Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate | Buffalo | New York | 14215 | — |
| The Zucker Hillside Hospital Northwell Health | Glen Oaks | New York | 11004 | — |
| Manhattan Behavioral Medicine | New York | New York | 10022 | — |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | — |
| University of Cincinnati | Cincinnati | Ohio | 45219 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73112 | — |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | — |
| Paradigm Research Professionals, LLC | Oklahoma City | Oklahoma | 73118 | — |
| UT Health Science Center at Houston (UTHSC-H) | Houston | Texas | 77054 | — |
| AIM Trials | Plano | Texas | 75093 | — |
| Research Across America | Plano | Texas | 75093 | — |
| Family Psychiatry Of The Woodlands | The Woodlands | Texas | 77381 | — |
| Fontaine Medical Laboratories | Charlottesville | Virginia | 22903 | — |
| Northridge Medical Plaza | Charlottesville | Virginia | 22903 | — |
| University of Virginia Center for Psychopharmacology Research in Youth | Charlottesville | Virginia | 22903 | — |
| UVA Child & Family Psychiatry Clinic | Charlottesville | Virginia | 22903 | — |
| Clinical Research Partners, LLC | Petersburg | Virginia | 23805 | — |
| Carilion Medical Center | Roanoke | Virginia | 24014 | — |
| Eastside Therapeutic Resource 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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02075047, 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 27, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02075047 live on ClinicalTrials.gov.