Safety and Efficacy Study of Lithium in Bipolar Disorder

Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Lithium in Bipolar I Disorder

NCT00422331•JDS Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether Lithium is safe and effective in the treatment of Bipolar I Disorder subjects with symptoms of acute mania.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of Bipolar 1 Disorder;
•Hospitalized or in the process of being hospitalized for a manic or mixed episode

Exclusion Criteria

•History of rapid cycling;
•History of hypersensitivity or adverse reaction to lithium

Locations (1)

JDS Pharmaceuticals

New York, New York, United States

Key Dates

Start Date

January 1, 2007

Completion Date

December 1, 2007

Last Updated

August 14, 2007

Enrollment

206

ESTIMATED participants

Conditions

Bipolar DisorderMania

Interventions

Lithium Carbonate Capsule

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

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RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy Study of Lithium in Bipolar Disorder

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations

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A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Early Intervention for Youth at High Risk for Bipolar Disorder