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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 Oct 20, 2026, 1:54 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
Feb 2005 (Type not available)
Primary completion
Not listed
Completion
Not listed
Last update posted
Jul 2, 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 2, 2007 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00195780 live on ClinicalTrials.gov.

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