NCT00221429 (PBC) is a Phase 3 clinical trial of Lithium in Bipolar Disorder, sponsored by Children's Hospital Medical Center, Cincinnati.

Who is sponsoring NCT00221429?

NCT00221429 is sponsored by Children's Hospital Medical Center, Cincinnati.

What drugs are being tested in NCT00221429?

Interventions in NCT00221429: Lithium, sodium divalproex, Placebo.

What condition does NCT00221429 study?

NCT00221429 studies Bipolar Disorder.

Is NCT00221429 still recruiting?

NCT00221429 is currently completed. Last updated 5 February 2024.

Last reviewed 2024-02-05 · How we verify

NCT00221429: PBC

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pediatric Bipolar Collaborative Mood Stabilizer Trial

Completed Phase 3 Last updated 5 February 2024

What this trial tests

Phase 3 trial testing Lithium in Bipolar Disorder in 153 participants. Completed in 1 February 2015.

Timeline

1 March 2001

Primary endpoint
1 August 2006

1 February 2015

Quick facts

Lead sponsor	Children's Hospital Medical Center, Cincinnati
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	153
Start date	1 March 2001
Primary completion	1 August 2006
Estimated completion	1 February 2015
Sites	1 location across United States

Drugs / interventions tested

Lithium
sodium divalproex
Placebo

Conditions studied

Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

Adults 7 to 18, any sex, with Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Young Mania Rating Scale (YMRS) & Clinical Global Impressions I (CGI-I)
Time frame: 8 weeks

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A randomized controlled trial of risperidone, lithium, or divalproex sodium for initial treatment of bipolar I disorder, manic or mixed phase, in children and adolescents.
Geller B, Luby JL, Joshi P, Wagner KD, et al · · 2012 · cited 130× · PMID 22213771 · DOI 10.1001/archgenpsychiatry.2011.1508

Verify or expand the search:

Other trials of Lithium

Trials testing the same drug.

NCT06929273 — A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3) · Phase 3 · recruiting
NCT05603104 — Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First- · Phase 3 · recruiting
NCT05973786 — The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in · Phase 3 · recruiting
NCT06729970 — A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects · Phase 1 · completed
NCT06051240 — Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy · Phase 2 · recruiting

Other recruiting trials for Bipolar Disorder

Currently open trials in the same condition.

NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
NCT06911931 — Visual Perception in Schizophrenia · NA · recruiting
NCT07316803 — Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness · NA · recruiting
NCT07479758 — Biomarker Research on Ultra-High-Field MRI Combined With Visual Perception Assessment in the Diagnosis and Treatment Out · recruiting
NCT07140913 — A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Featur · Phase 3 · recruiting

Other Children's Hospital Medical Center, Cincinnati trials

Trials by the same sponsor.

NCT07430332 — GLP-1 RA for Stage 1 Type 1 Diabetes · Phase 2 · not yet recruiting
NCT07077213 — 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) in Tuberculosis Patients · recruiting
NCT07265141 — An Automated Virtual Reality Intervention to Enhance Firearm Safety Counseling in Pediatrics · NA · not yet recruiting
NCT07217444 — Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation · NA · recruiting
NCT07195123 — Evaluation of the SMART IBD App in Pediatric IBD · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00221429 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati
Last refreshed: 5 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00221429.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing