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Completed Phase 3 Interventional

A Study for the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents

ClinicalTrials.gov ID: NCT00195780

Public ClinicalTrials.gov record NCT00195780. 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.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 6:24 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label Study to Evaluate the Safety of Depakote ER in the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of the study is to evaluate the long-term safety profile of the Investigational Medication Depakote ER in the treatment of Bipolar I Disorder, manic or mixed episode, in children and adolescents ages 10-17.

Study identification

NCT ID
NCT00195780
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Abbott
Industry
Enrollment
227 participants

Conditions and interventions

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
Jan 31, 2005
Primary completion
Not listed
Completion
Not listed
Last update posted
Jul 1, 2007

Started 2005

United States locations

U.S. sites
29
U.S. states
18
U.S. cities
28
Facility City State ZIP Site status
PCSD Feighner Research San Diego California 92111
PCSD Feighner Research San Marcos California 92078
Not listed Altamonte Springs Florida 32701
Segal Institute for Clinical Research Fort Lauderdale Florida 33319
Sarkis Clinical Trials Gainesville Florida 32607
Segal Institute for Clinical Research North Miami Florida 33161
Kolin Research Group Winter Park Florida 32789
Northlake Medical Research Center Decatur Georgia 30033
Mountain West Clinical Trials Eagle Idaho 83616
Capstone Clinical Research Libertyville Illinois 60048
Clinco Terre Haute Indiana 47802
Cientifica Inc. Newton Kansas 67114
Psychiatric Associates Overland Park Kansas 66211
Brentwood Research Institute Shreveport Louisiana 71101
Acadia Hospital Bangor Maine 04402-0422
Pharmasite Research Baltimore Maryland 21208
North Carolina Neuropsychiatry, PA Chapel Hill North Carolina 27514
Odyssey Research Fargo North Dakota 58104
Neuro Behavioral Clinical Research, INC. Canton Ohio 44708
Psychiatric Professional Services Cincinnati Ohio 45267-0559
Rakesh Ranjan, M.D. & Associates, Inc. Lyndhurst Ohio 44124
IPS Research Oklahoma City Oklahoma 73103
Cutting Edge Research Group Oklahoma City Oklahoma 73120
Clinical Trials Specialists Bala-Cynwyd Pennsylvania 19004-1604
UTHSC, Sept. of Psychiatry, College of Medicine Memphis Tennessee 38105
InSite Clinical Research DeSoto Texas 75115
Red Oak Psychiatry Houston Texas 77090
R/D Clinical Research Lake Jackson Texas 77566
Northwest Clinical Research Center Bellevue Washington 98004

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 NCT00195780, 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 Jul 1, 2007 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00195780 live on ClinicalTrials.gov.

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