The Young Adult and Pediatric Bipolar Study
Public ClinicalTrials.gov record NCT00350857. 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 IV, Multi-Center, Open-Label, Safety and Effectiveness Study of Extended-Release Carbamazepine in the Treatment of Mania in Children and Adolescents Aged 10-17 Years With Acute Manic or Mixed Bipolar I Disorder.
Study identification
- NCT ID
- NCT00350857
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Lead sponsor
- Validus Pharmaceuticals
- Industry
- Enrollment
- 161 participants
Conditions and interventions
Conditions
Interventions
- Extended-Release Carbamazepine Drug
Drug
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
- Jun 30, 2006
- Primary completion
- Sep 30, 2007
- Completion
- Sep 30, 2007
- Last update posted
- Feb 19, 2014
2006 – 2007
United States locations
- U.S. sites
- 26
- U.S. states
- 16
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 11 Shire Clinical Research Site | Altamonte Springs | Florida | 32701 | — |
| 17 Segal Institute for Clinical Research | Fort Lauderdale | Florida | 33319 | — |
| 19 Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| 23 Shire Clinical Research Site | Jacksonville | Florida | 32256 | — |
| 21 Scientific Clinical Research | North Miami | Florida | 33161 | — |
| 14 Northlake Medical Research | Decatur | Georgia | 30333 | — |
| 04 Mountain West Clinical Trials | Eagle | Idaho | 83616 | — |
| 25 Capstone Clinical Research | Libertyville | Illinois | 60048 | — |
| 15 Psychiatric Associates | Overland Park | Kansas | 66211 | — |
| 27 Owensboro Behavioral Care | Owensboro | Kentucky | 42303 | — |
| 05 Brentwood Research Institute | Shreveport | Louisiana | 71101 | — |
| 13 Pharmasite Research, Inc | Baltimore | Maryland | 21208 | — |
| 02 Finger Lakes Clinical Research | Rochester | New York | 14618 | — |
| 01 Nccacrf | Chapel Hill | North Carolina | 27514 | — |
| 06 University of Cincinnati, College of Medicine | Cincinnati | Ohio | 45267 | — |
| 09 Discovery and Wellness Center for Children | Cleveland | Ohio | 44106 | — |
| 03 IPS Research | Oklahoma City | Oklahoma | 73103 | — |
| 26 Suburban Research Associates | Media | Pennsylvania | 19063 | — |
| 12 Claghorn-Lesem Research Clinic | Bellaire | Texas | 77401 | — |
| 07 Center for Pediatric Psychiatry | Dallas | Texas | 75235 | — |
| 24 Red Oak Psychiatry Associates | Houston | Texas | 77090 | — |
| 10 RID Clinical Research, Inc | Lake Jackson | Texas | 77566 | — |
| 08 Dominion Clinical Research | Midlothian | Virginia | 23112 | — |
| 22 Brighton Research Group | Virginia Beach | Virginia | 23452 | — |
| 20 Shire Clinical Research Site | Milwaukee | Wisconsin | 53201 | — |
| 16 Rogers Center for Research and Training | Milwaukee | Wisconsin | 53227 | — |
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 NCT00350857, 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 Feb 19, 2014 · Synced Jul 22, 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 protocol, eligibility criteria, and contact information for NCT00350857 live on ClinicalTrials.gov.