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Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder

NCT00221429 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2024-02-08

No results posted yet for this study

Summary

This study compared the efficacy of lithium, divalproex, and placebo in treating the acute phase of symptomatic bipolar I disorder, mixed or manic episode, in children and adolescents.

Conditions

Interventions

DRUG

Lithium

lithium

DRUG

sodium divalproex

Depakote

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Robert A. Kowatch, MD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-03-31
Primary Completion
2006-08-31
Completion
2015-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00221429 on ClinicalTrials.gov